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Cetuximab and Bevacizumab With or Without Gemcitabine to Treat Metastatic Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT00326911
Recruitment Status : Terminated (The planned enrollment was 130 patients and the study was halted prematurely due to lack of efficacy in both arms. Enrolled patients continued treatment.)
First Posted : May 17, 2006
Results First Posted : December 4, 2009
Last Update Posted : May 25, 2011
Sponsor:
Information provided by:
ImClone LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Metastatic Pancreatic Cancer
Interventions Biological: cetuximab
Biological: bevacizumab
Drug: gemcitabine
Enrollment 61
Recruitment Details Patients were recruited from a population of pancreatic cancer patients treated at investigational centers.
Pre-assignment Details Prior chemotherapy, hormonal therapy, radiation therapy in the adjuvant setting were allowed, provided that the last date of therapy was at least 6 months prior to randomization.
Arm/Group Title Cetuximab + Bevacizumab + Gemcitabine Cetuximab + Bevacizumab
Hide Arm/Group Description Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab. Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
Period Title: Overall Study
Started 30 [1] 31 [1]
Completed 29 [2] 29 [2]
Not Completed 1 2
Reason Not Completed
Hospitalization prior to treatment             0             1
Physician decision prior to treatment             1             0
Withdrawal by subject prior to treatment             0             1
[1]
This number reflects all randomized patients.
[2]
This number reflects all treated patients.
Arm/Group Title Cetuximab + Bevacizumab + Gemcitabine Cetuximab + Bevacizumab Total
Hide Arm/Group Description Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab. Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab. Total of all reporting groups
Overall Number of Baseline Participants 30 31 61
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 31 participants 61 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
18
  60.0%
18
  58.1%
36
  59.0%
>=65 years
12
  40.0%
13
  41.9%
25
  41.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 31 participants 61 participants
62.7  (11.6) 62.2  (11.4) 62.4  (11.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 31 participants 61 participants
Female
11
  36.7%
15
  48.4%
26
  42.6%
Male
19
  63.3%
16
  51.6%
35
  57.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 30 participants 31 participants 61 participants
30 31 61
1.Primary Outcome
Title Progression-free Survival (PFS)
Hide Description Progression-free survival is the time from randomization until the date of progressive disease (PD) or death from any cause whichever is first reported. Patients who die without a reported prior progression were considered to have progresssed on the day of their death. Patients who did not progress were censored at the day of their last tumor assessment.
Time Frame Time from randomization to disease progression or death from any cause (Range: 0 -10 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The PFS was based on the modified Intent-to-Treat (mITT) population, which included any patient who enrolled, was randomized, and received any quantity of study drug.
Arm/Group Title Cetuximab + Bevacizumab + Gemcitabine Cetuximab + Bevacizumab
Hide Arm/Group Description:
Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
Overall Number of Participants Analyzed 29 29
Median (95% Confidence Interval)
Unit of Measure: months
3.55
(2.00 to 5.59)
1.91
(1.81 to 2.76)
2.Secondary Outcome
Title Overall Survival (OS)
Hide Description This measure is defined as the time from randomization to the date of death due to any cause. Survival of living patients or those who lost to follow-up were censored on the last date the patients were known to be alive.
Time Frame Survival information was collected continuously every 3 months after completion of therapy and/or follow-up (range: 1-19 months).
Hide Outcome Measure Data
Hide Analysis Population Description
The overall survival was based on the mITT population.
Arm/Group Title Cetuximab + Bevacizumab + Gemcitabine Cetuximab + Bevacizumab
Hide Arm/Group Description:
Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
Overall Number of Participants Analyzed 29 29
Median (95% Confidence Interval)
Unit of Measure: Months
5.41
(3.84 to 6.74)
4.17
(2.69 to 8.74)
3.Secondary Outcome
Title The Number of Patients With a Best Overall Response of Either a Complete Response (CR) or Partial Response (PR)
Hide Description The best overall response is the number of patients with a best overall response of CR or PR, as classifed by the investigator according to the RECIST guidelines. A CR is the disappearance of all target lesions and a PR is at least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter.
Time Frame Tumor evaluations were performed every 8 weeks while on cetuximab therapy until PD or recurrence. Patients with a PR or CR had a confirmatory tumor assessment no less than 4 weeks after the initial evaluation.
Hide Outcome Measure Data
Hide Analysis Population Description
The best overall response was based on the mITT population for those patients who either had a CR or PR.
Arm/Group Title Cetuximab + Bevacizumab + Gemcitabine Cetuximab + Bevacizumab
Hide Arm/Group Description:
Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
Overall Number of Participants Analyzed 29 29
Measure Type: Number
Unit of Measure: Participants
4 0
4.Secondary Outcome
Title Percentage of Patients With Carbohydrate Antigen 19-9 (CA19-9) Response at End of Cycle 2 in Patients With Elevated Baseline Values (Equal or Greater Than 2 x Upper Limit of Normal).
Hide Description CA19-9 is a tumor marker for pancreatic cancer and the level usually increases as the disease is progressing. The CA19-9 response was the percentage of patients whose CA19-9 level was declining, stable or increasing < 10% compared with baseline, divided by the total patients with elevated baseline CA19-9 in that arm.
Time Frame First day of treatment to the end of Cycle 2, Week 1
Hide Outcome Measure Data
Hide Analysis Population Description
The CA19-9 response rate was calculated for at least the 15 patients in each arm of the study at the end of the first two cycles of therapy (8 weeks) in the mITT population who had elevated CA19-9 levels at baseline.
Arm/Group Title Cetuximab + Bevacizumab + Gemcitabine Cetuximab + Bevacizumab
Hide Arm/Group Description:
Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
Overall Number of Participants Analyzed 18 19
Measure Type: Number
Unit of Measure: Percentage of participants
8 9
5.Secondary Outcome
Title Time to Progression (TTP)
Hide Description Time to progression was defined as the time from randomization until the date of objectively confirmed tumor progression was first reported. The censoring rule was consistent with PFS except death. Patients who died from any cause were censored at the time of death or at last tumor assessment date if the death date was missing. For patients lost to follow-up, they were censored at the last tumor assessment date.
Time Frame Time from randomization until the date of objective tumor progression was first reported (range: 11 -38 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The TTP was based on the mITT population. For patients lost to follow-up, they were censored at the next scheduled visit.
Arm/Group Title Cetuximab + Bevacizumab + Gemcitabine Cetuximab + Bevacizumab
Hide Arm/Group Description:
Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
Overall Number of Participants Analyzed 29 29
Median (95% Confidence Interval)
Unit of Measure: months
4.11
(2.17 to 5.95)
2.07
(1.84 to 4.01)
6.Secondary Outcome
Title Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description Reported AEs per patient were coded according to the corresponding preferred term and system organ class in the Medical Dictionary for regulatory Activities dictionary. The National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 3.0 was used to grade all AEs. The collection of AEs began at the time the patient received the first cetuximab dose and continued during the study until 30 days after the last dose of cetuximab. All patients who were enrolled and treated with cetuximab were assessed for safety (mITT population, as treated).
Time Frame An AE was included in the safety analysis if its onset date occurred anytime during cetuximab treatment or up to 30 days after the last dose of cetuximab.
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received any quantity of study therapy were included in the safety evaluation (safety population, as treated).
Arm/Group Title Cetuximab + Bevacizumab + Gemcitabine Cetuximab + Bevacizumab
Hide Arm/Group Description:
Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
Overall Number of Participants Analyzed 29 29
Measure Type: Number
Unit of Measure: Participants
29 29
7.Secondary Outcome
Title Change From Baseline in Quality of Life (QoL) Assessment Using the Linear Analog Scale Assessment (LASA), Overall QoL at Cycle 2 Week 4
Hide Description Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic cancer symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Overall QoL question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A negative score indicates worsening from baseline.
Time Frame Screening, and then every 8 weeks while receiving study drug to 30-day follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population
Arm/Group Title Cetuximab + Bevacizumab + Gemcitabine Cetuximab + Bevacizumab
Hide Arm/Group Description:
Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
Overall Number of Participants Analyzed 17 12
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-0.9  (2.9) -0.9  (2.3)
8.Secondary Outcome
Title Change From Baseline in QoL Assessment Using LASA, Overall Mental Well Being, at Cycle 2 Week 4
Hide Description Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic cancer symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Overall Mental Well Being question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A negative score indicates worsening from baseline.
Time Frame Screening, and then every 8 weeks while receiving study drug to 30-day follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population
Arm/Group Title Cetuximab + Bevacizumab + Gemcitabine Cetuximab + Bevacizumab
Hide Arm/Group Description:
Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
Overall Number of Participants Analyzed 17 11
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
0.6  (2.0) -0.8  (1.4)
9.Secondary Outcome
Title Change From Baseline in QoL Assessment Using LASA, Overall Physical Well Being, at Cycle 2 Week 4
Hide Description Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic cancer symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Overall Physical Well Being question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A negative score indicates worsening from baseline.
Time Frame Screening, and then every 8 weeks while receiving study drug to 30-day follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population
Arm/Group Title Cetuximab + Bevacizumab + Gemcitabine Cetuximab + Bevacizumab
Hide Arm/Group Description:
Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
Overall Number of Participants Analyzed 17 12
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-0.6  (3.1) -0.6  (1.7)
10.Secondary Outcome
Title Change From Baseline in QoL Assessment Using LASA, Overall Emotional Well Being, at Cycle 2 Week 4
Hide Description Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic cancer symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Overall Emotional Well Being question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A negative score indicates worsening from baseline.
Time Frame Screening, and then every 8 weeks while receiving study drug to 30-day follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population
Arm/Group Title Cetuximab + Bevacizumab + Gemcitabine Cetuximab + Bevacizumab
Hide Arm/Group Description:
Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
Overall Number of Participants Analyzed 17 11
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-0.2  (2.8) -1.1  (2.1)
11.Secondary Outcome
Title Change From Baseline in QoL Assessment Using LASA, Level of Social Activity, at Cycle 2 Week 4
Hide Description Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic cancer symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Level of Social Activity question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A negative score indicates worsening from baseline.
Time Frame Screening, and then every 8 weeks while receiving study drug to 30-day follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population
Arm/Group Title Cetuximab + Bevacizumab + Gemcitabine Cetuximab + Bevacizumab
Hide Arm/Group Description:
Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
Overall Number of Participants Analyzed 17 12
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-1.1  (2.9) 0.6  (2.3)
12.Secondary Outcome
Title Change From Baseline in QoL Assessment Using LASA, Overall Spiritual Well Being, at Cycle 2 Week 4
Hide Description Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Overall Spiritual Well Being question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A negative score indicates worsening from baseline.
Time Frame Screening, and then every 8 weeks while receiving study drug to 30-day follow-up while receiving study drug
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population
Arm/Group Title Cetuximab + Bevacizumab + Gemcitabine Cetuximab + Bevacizumab
Hide Arm/Group Description:
Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
Overall Number of Participants Analyzed 17 11
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-0.4  (1.8) -0.3  (1.1)
13.Secondary Outcome
Title Change From Baseline in QoL Assessment Using LASA, Frequency of Pain, at Cycle 2 Week 4
Hide Description Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic cancer symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Frequency of Pain question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A negative score indicates improvement from baseline.
Time Frame Screening, and then every 8 weeks while receiving study drug to 30-day follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population
Arm/Group Title Cetuximab + Bevacizumab + Gemcitabine Cetuximab + Bevacizumab
Hide Arm/Group Description:
Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
Overall Number of Participants Analyzed 17 12
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-1.5  (2.9) -2.3  (2.6)
14.Secondary Outcome
Title Change From Baseline in QoL Assessment Using LASA, Severity of Pain, Average, at Cycle 2 Week 4
Hide Description Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic cancer symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Severity of Pain question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A positive score indicates improvement from baseline.
Time Frame Screening, and then every 8 weeks while receiving study drug to 30-day follow-up while receiving study drug
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population
Arm/Group Title Cetuximab + Bevacizumab + Gemcitabine Cetuximab + Bevacizumab
Hide Arm/Group Description:
Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
Overall Number of Participants Analyzed 17 12
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-0.5  (2.8) -0.9  (2.4)
15.Secondary Outcome
Title Change From Baseline in QoL Assessment Using LASA, Level of Fatigue, Average, at Cycle 2 Week 4
Hide Description Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic cancer symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Level of Fatigue question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A positive score indicates improvement from baseline.
Time Frame Screening, and then every 8 weeks while receiving study drug to 30-day follow-up
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mITT Population
Arm/Group Title Cetuximab + Bevacizumab + Gemcitabine Cetuximab + Bevacizumab
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Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
Overall Number of Participants Analyzed 17 12
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
1.5  (2.3) 0.3  (2.6)
16.Secondary Outcome
Title Change From Baseline in QoL Assessment Using LASA, Level of Support, Friends and Family, at Cycle 2 Week 4
Hide Description Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic cancer symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Level of Support, Friends and Family question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A negative score indicates worsening from baseline.
Time Frame Screening, and then every 8 weeks while receiving study drug to 30-day follow-up
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mITT Population
Arm/Group Title Cetuximab + Bevacizumab + Gemcitabine Cetuximab + Bevacizumab
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Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
Overall Number of Participants Analyzed 17 12
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
0.1  (1.3) -0.8  (1.5)
17.Secondary Outcome
Title Change From Baseline in QoL Assessment Using LASA, Financial Concerns, at Cycle 2 Week 4
Hide Description Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic cancer symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Financial Concerns Question question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A negative score indicates worsening from baseline.
Time Frame Screening, and then every 8 weeks while receiving study drug to 30-day follow-up
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mITT population
Arm/Group Title Cetuximab + Bevacizumab + Gemcitabine Cetuximab + Bevacizumab
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Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
Overall Number of Participants Analyzed 17 12
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-0.1  (2.4) 0.9  (3.7)
18.Secondary Outcome
Title Change From Baseline in QoL Assessment Using LASA, Legal Concerns, at Cycle 2 Week 4
Hide Description Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic cancer symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Legal Concerns question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A negative score indicates worsening from baseline.
Time Frame Screening, and then every 8 weeks while receiving study drug to 30-day follow-up
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mITT population
Arm/Group Title Cetuximab + Bevacizumab + Gemcitabine Cetuximab + Bevacizumab
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Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
Overall Number of Participants Analyzed 17 12
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
0.4  (1.7) 2.3  (3.2)
19.Secondary Outcome
Title Change From Baseline in Assessment of Pain Using the Brief Pain Inventory (BPI) Short Form, Worst Pain, at Cycle 2 Week 4
Hide Description Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. Analysis of pain using the BPI was considered exploratory. The Worst Pain (change from baseline) to Cycle 2 Week 4 is reported. The worst pain is 10 and no pain is 0. A negative score indicates improvement from baseline.
Time Frame Screening, and then every 8 weeks while receiving study drug to 30-day follow-up
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mITT population
Arm/Group Title Cetuximab + Bevacizumab + Gemcitabine Cetuximab + Bevacizumab
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Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
Overall Number of Participants Analyzed 17 12
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-1.2  (2.8) 0.5  (2.5)
20.Secondary Outcome
Title Change From Baseline in Assessment of Pain Using BPI Short Form, Least Pain, at Cycle 2 Week 4
Hide Description Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. Analysis of pain using the BPI was considered exploratory. The Least Pain (change from baseline) to Cycle 2 Week 4 is reported. The worst pain is 10 and no pain is 0. A negative score indicates improvement from baseline.
Time Frame Screening, and then every 8 weeks while receiving study drug to 30-day follow-up
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mITT population
Arm/Group Title Cetuximab + Bevacizumab + Gemcitabine Cetuximab + Bevacizumab
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Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
Overall Number of Participants Analyzed 17 12
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-0.4  (2.0) 0.9  (2.4)
21.Secondary Outcome
Title Change From Baseline in Assessment of Pain Using BPI Short Form, Average Pain, at Cycle 2 Week 4
Hide Description Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. Analysis of pain using the BPI was considered exploratory. The Average Pain (change from baseline) to Cycle 2 Week 4 is reported. The worst pain was 10 and no pain is 0. A negative score indicates improvement from baseline.
Time Frame Screening, and then every 8 weeks while receiving study drug to 30-day follow-up
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Hide Analysis Population Description
mITT population
Arm/Group Title Cetuximab + Bevacizumab + Gemcitabine Cetuximab + Bevacizumab
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Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
Overall Number of Participants Analyzed 17 12
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-0.6  (1.8) -0.2  (2.1)
22.Secondary Outcome
Title Change From Baseline in Assessment of Pain Using BPI Short Form, Pain Right Now, at Cycle 2 Week 4
Hide Description Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. Analysis of pain using the BPI was considered exploratory. The Pain Right Now question (change from baseline) to Cycle 2 Week 4 is reported. The worst pain is 10 and no pain is 0. A negative score indicates improvement from baseline.
Time Frame Screening, and then every 8 weeks while receiving study drug to 30-day follow-up
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Hide Analysis Population Description
mITT population
Arm/Group Title Cetuximab + Bevacizumab + Gemcitabine Cetuximab + Bevacizumab
Hide Arm/Group Description:
Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
Overall Number of Participants Analyzed 17 12
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-0.9  (2.6) 0.9  (2.0)
23.Secondary Outcome
Title Change From Baseline in Assessment of Pain Using BPI Short Form, Interference, at Cycle 2 Week 4
Hide Description Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. Analysis of pain using the BPI was considered exploratory. The Interference question (change from baseline) to Cycle 2 Week 4 is reported. Complete interference is scored as 10 and no interference is scored as 0. A negative score indicates improvement from baseline.
Time Frame Screening, and then every 8 weeks while receiving study drug to 30-day follow-up
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mITT population
Arm/Group Title Cetuximab + Bevacizumab + Gemcitabine Cetuximab + Bevacizumab
Hide Arm/Group Description:
Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
Overall Number of Participants Analyzed 16 12
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-0.2  (2.3) 0.8  (2.9)
Time Frame Adverse events were collected beginning at the time the patient received the initial cetuximab infusion and continued throughout the study until 30 days after the last dose.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cetuximab + Bevacizumab + Gemcitabine Cetuximab + Bevacizumab
Hide Arm/Group Description Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab. Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
All-Cause Mortality
Cetuximab + Bevacizumab + Gemcitabine Cetuximab + Bevacizumab
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Cetuximab + Bevacizumab + Gemcitabine Cetuximab + Bevacizumab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   21/29 (72.41%)      16/29 (55.17%)    
Blood and lymphatic system disorders     
Thrombocytopenia  1  1/29 (3.45%)  1 0/29 (0.00%)  0
Cardiac disorders     
Atrial Fibrillation  1  1/29 (3.45%)  1 0/29 (0.00%)  0
Cardio-Respiratory Arrest  1  1/29 (3.45%)  1 0/29 (0.00%)  0
Gastrointestinal disorders     
Abdominal Pain  1  4/29 (13.79%)  5 1/29 (3.45%)  1
Nausea  1  2/29 (6.90%)  2 3/29 (10.34%)  3
Vomiting  1  1/29 (3.45%)  1 4/29 (13.79%)  4
Gastrointestinal Haemorrhage  1  1/29 (3.45%)  2 2/29 (6.90%)  3
Diarrhoea  1  0/29 (0.00%)  0 2/29 (6.90%)  2
Upper abdominal pain  2  0/29 (0.00%)  0 1/29 (3.45%)  1
Constipation  2  1/29 (3.45%)  1 0/29 (0.00%)  0
Gastric outlet obstruction  2  0/29 (0.00%)  0 1/29 (3.45%)  1
Intestinal obstruction  2  1/29 (3.45%)  1 0/29 (0.00%)  0
Small intestinal obstruction  2  0/29 (0.00%)  0 1/29 (3.45%)  1
General disorders     
Disease progression  2  5/29 (17.24%)  5 9/29 (31.03%)  9
Fatigue  2  2/29 (6.90%)  2 0/29 (0.00%)  0
Pyrexia  2  1/29 (3.45%)  1 1/29 (3.45%)  1
Asthenia  2  1/29 (3.45%)  1 0/29 (0.00%)  0
Death  2  1/29 (3.45%)  1 0/29 (0.00%)  0
No adverse drug effect  2  0/29 (0.00%)  0 1/29 (3.45%)  1
Hepatobiliary disorders     
Hepatic failure  2  1/29 (3.45%)  1 0/29 (0.00%)  0
Hyperbilirubinemia  2  0/29 (0.00%)  0 1/29 (3.45%)  1
Portal vein thrombosis  2  1/29 (3.45%)  1 0/29 (0.00%)  0
Infections and infestations     
Urinary tract infection  2  2/29 (6.90%)  2 1/29 (3.45%)  1
Cellulitis  2  2/29 (6.90%)  3 0/29 (0.00%)  0
Enterococcal sepsis  2  1/29 (3.45%)  1 0/29 (0.00%)  0
Otitis exterma  2  1/29 (3.45%)  1 0/29 (0.00%)  0
Pyelonephritis  2  1/29 (3.45%)  1 0/29 (0.00%)  0
Sepsis  2  1/29 (3.45%)  1 0/29 (0.00%)  0
Septic shock  2  1/29 (3.45%)  1 0/29 (0.00%)  0
Injury, poisoning and procedural complications     
Feeding tube complication  2  0/29 (0.00%)  0 1/29 (3.45%)  1
Overdose  2  1/29 (3.45%)  1 0/29 (0.00%)  0
Stent occlusion  2  0/29 (0.00%)  0 1/29 (3.45%)  1
Investigations     
Increased alanine aminotransferase  2  0/29 (0.00%)  0 1/29 (3.45%)  1
Increased aspartate aminotransferase  2  0/29 (0.00%)  0 1/29 (3.45%)  1
Metabolism and nutrition disorders     
Failure to thrive  2  2/29 (6.90%)  2 0/29 (0.00%)  0
Anorexia  2  1/29 (3.45%)  1 0/29 (0.00%)  0
Dehydration  2  1/29 (3.45%)  1 0/29 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Back pain  2  1/29 (3.45%)  1 0/29 (0.00%)  0
Nervous system disorders     
Cerebrovascular accident  2  1/29 (3.45%)  2 1/29 (3.45%)  1
Cerebral hemorrhage  2  1/29 (3.45%)  2 0/29 (0.00%)  0
Sedation  2  0/29 (0.00%)  0 1/29 (3.45%)  1
Renal and urinary disorders     
Acute renal failure  2  0/29 (0.00%)  0 2/29 (6.90%)  2
Renal failure  2  1/29 (3.45%)  1 0/29 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Pulmonary embolism  2  6/29 (20.69%)  6 2/29 (6.90%)  2
Dyspnea  2  2/29 (6.90%)  2 0/29 (0.00%)  0
Chronic obstructive pulmonary disease  2  1/29 (3.45%)  1 0/29 (0.00%)  0
Skin and subcutaneous tissue disorders     
Acneiform dermatitis  2  0/29 (0.00%)  0 1/29 (3.45%)  1
Vascular disorders     
Deep vein thrombosis  2  2/29 (6.90%)  2 0/29 (0.00%)  0
Hypotension  2  0/29 (0.00%)  0 2/29 (6.90%)  2
Arterial occlusive disease  2  1/29 (3.45%)  1 0/29 (0.00%)  0
Hypertension  2  0/29 (0.00%)  0 1/29 (3.45%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 8.0
2
Term from vocabulary, MedDRA (10.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cetuximab + Bevacizumab + Gemcitabine Cetuximab + Bevacizumab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   29/29 (100.00%)      29/29 (100.00%)    
Blood and lymphatic system disorders     
Anemia  1  9/29 (31.03%)  23 1/29 (3.45%)  1
Neutropenia  1  9/29 (31.03%)  21 0/29 (0.00%)  0
Thrombocytopenia  1  9/29 (31.03%)  22 0/29 (0.00%)  0
Leukopenia  1  3/29 (10.34%)  6 0/29 (0.00%)  0
Cardiac disorders     
Tachycardia  1  1/29 (3.45%)  1 2/29 (6.90%)  2
Cardiomegaly  1  2/29 (6.90%)  2 0/29 (0.00%)  0
Constipation  1  11/29 (37.93%)  12 7/29 (24.14%)  7
Gastrointestinal disorders     
Nausea  1  14/29 (48.28%)  19 14/29 (48.28%)  20
Vomiting  1  11/29 (37.93%)  17 9/29 (31.03%)  12
Stomatitis  1  9/29 (31.03%)  13 7/29 (24.14%)  8
Diarrhea  1  9/29 (31.03%)  10 4/29 (13.79%)  4
Abdominal pain  1  4/29 (13.79%)  6 2/29 (6.90%)  2
Abdominal distention  1  2/29 (6.90%)  2 3/29 (10.34%)  3
Upper abdominal pain  1  3/29 (10.34%)  3 2/29 (6.90%)  2
Dyspepsia  1  1/29 (3.45%)  1 4/29 (13.79%)  4
Oral pain  1  2/29 (6.90%)  2 2/29 (6.90%)  2
Flatulence  1  2/29 (6.90%)  2 0/29 (0.00%)  0
Hemorrhoids  1  2/29 (6.90%)  2 0/29 (0.00%)  0
General disorders     
Fatigue  1  20/29 (68.97%)  32 10/29 (34.48%)  13
Pyrexia  1  8/29 (27.59%)  9 3/29 (10.34%)  3
Peripheral edema  1  7/29 (24.14%)  11 3/29 (10.34%)  5
Chills  1  4/29 (13.79%)  5 3/29 (10.34%)  3
Infusion related reaction  1  3/29 (10.34%)  4 2/29 (6.90%)  2
Pain  1  2/29 (6.90%)  2 3/29 (10.34%)  3
Asthenia  1  2/29 (6.90%)  2 0/29 (0.00%)  0
Malaise  1  2/29 (6.90%)  2 0/29 (0.00%)  0
Hepatobiliary disorders     
Jaundice  1  3/29 (10.34%)  3 2/29 (6.90%)  2
Bile duct obstruction  1  2/29 (6.90%)  2 0/29 (0.00%)  0
Hyperbilirubinemia  1  2/29 (6.90%)  2 0/29 (0.00%)  0
Cholestatic jaundice  1  2/29 (6.90%)  2 0/29 (0.00%)  0
Infections and infestations     
Urinary tract infection  1  4/29 (13.79%)  4 2/29 (6.90%)  2
Upper respiratory tract infection  1  0/29 (0.00%)  0 2/29 (6.90%)  2
Metabolism and nutrition disorders     
Anorexia  1  13/29 (44.83%)  19 9/29 (31.03%)  12
Dehydration  1  4/29 (13.79%)  4 6/29 (20.69%)  8
Hypomagnesemia  1  7/29 (24.14%)  12 3/29 (10.34%)  3
Hypokalemia  1  5/29 (17.24%)  11 3/29 (10.34%)  3
Hyperglycemia  1  2/29 (6.90%)  3 2/29 (6.90%)  2
Hyperkalemia  1  3/29 (10.34%)  3 0/29 (0.00%)  0
Decreased appetite  1  0/29 (0.00%)  0 2/29 (6.90%)  2
Hypermagnesemia  1  2/29 (6.90%)  2 0/29 (0.00%)  0
Hypocalcemia  1  2/29 (6.90%)  2 0/29 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Extremity pain  1  3/29 (10.34%)  3 1/29 (3.45%)  1
Back pain  1  1/29 (3.45%)  1 2/29 (6.90%)  2
Musculoskeletal chest pain  1  2/29 (6.90%)  2 1/29 (3.45%)  1
Myalgia  1  3/29 (10.34%)  4 0/29 (0.00%)  0
Muscular weakness  1  2/29 (6.90%)  2 0/29 (0.00%)  0
Nervous system disorders     
Headache  1  6/29 (20.69%)  14 5/29 (17.24%)  5
Dizziness  1  5/29 (17.24%)  5 1/29 (3.45%)  1
Dysgeusia  1  3/29 (10.34%)  3 2/29 (6.90%)  2
Psychiatric disorders     
Depression  1  5/29 (17.24%)  6 4/29 (13.79%)  4
Anxiety  1  3/29 (10.34%)  3 4/29 (13.79%)  4
Insomnia  1  4/29 (13.79%)  4 2/29 (6.90%)  2
Confusional state  1  1/29 (3.45%)  2 2/29 (6.90%)  2
Mental Disorder  1  0/29 (0.00%)  0 2/29 (6.90%)  2
Renal and urinary disorders     
Proteinuria  1  6/29 (20.69%)  7 2/29 (6.90%)  2
Acute renal failure  1  2/29 (6.90%)  2 0/29 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Dyspnea  1  8/29 (27.59%)  10 4/29 (13.79%)  4
Epistaxis  1  4/29 (13.79%)  4 3/29 (10.34%)  3
Cough  1  3/29 (10.34%)  3 1/29 (3.45%)  1
Dysphonia  1  3/29 (10.34%)  3 0/29 (0.00%)  0
Exertional dyspnea  1  2/29 (6.90%)  2 1/29 (3.45%)  1
Pharyngolaryngeal pain  1  1/29 (3.45%)  1 2/29 (6.90%)  2
Hiccups  1  2/29 (6.90%)  2 0/29 (0.00%)  0
Pulmonary embolism  1  2/29 (6.90%)  2 0/29 (0.00%)  0
Acneiform dermatitis  1  22/29 (75.86%)  48 21/29 (72.41%)  27
Pruritus  1  5/29 (17.24%)  5 2/29 (6.90%)  2
Skin and subcutaneous tissue disorders     
Skin disorder  1  1/29 (3.45%)  2 5/29 (17.24%)  5
Dry skin  1  4/29 (13.79%)  4 1/29 (3.45%)  1
Rash  1  2/29 (6.90%)  2 3/29 (10.34%)  4
Alopecia  1  4/29 (13.79%)  4 0/29 (0.00%)  0
Photosensitivity reaction  1  2/29 (6.90%)  2 0/29 (0.00%)  0
Vascular disorders     
Deep vein thrombosis  1  4/29 (13.79%)  5 1/29 (3.45%)  1
Hypertension  1  2/29 (6.90%)  2 2/29 (6.90%)  3
Hypotension  1  2/29 (6.90%)  2 1/29 (3.45%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Accrual on the trial was stopped earlier than planned due to insufficient efficacy in both arms.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Investigators agreed to delay independently publishing or disclosing data, findings or conclusions from the study except as part of a multi-center publication. Upon study publication or if draft publication is not produced within approximately 6 months of the final report of the study results, investigators may independently publish, subject to confidential information review/redaction by sponsor. Sponsor may request publication delay up to 90 days to seek patent protection.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: ImClone LLC
EMail: ClinicalTrials@ImClone.com
Layout table for additonal information
Responsible Party: Chief Medical Officer, ImClone LLC
ClinicalTrials.gov Identifier: NCT00326911     History of Changes
Other Study ID Numbers: CP02-0555
First Submitted: May 15, 2006
First Posted: May 17, 2006
Results First Submitted: November 3, 2009
Results First Posted: December 4, 2009
Last Update Posted: May 25, 2011