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Bevacizumab and Gemcitabine Combined With Either Cetuximab or Erlotinib in Treating Patients With Advanced Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT00091026
Recruitment Status : Completed
First Posted : September 8, 2004
Results First Posted : November 20, 2013
Last Update Posted : May 15, 2014
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Adenocarcinoma of the Pancreas
Recurrent Pancreatic Cancer
Stage II Pancreatic Cancer
Stage III Pancreatic Cancer
Stage IV Pancreatic Cancer
Interventions Biological: cetuximab
Drug: gemcitabine hydrochloride
Biological: bevacizumab
Drug: erlotinib hydrochloride
Enrollment 143
Recruitment Details Patients were enrolled at sixteen sites between September 2004 and February 2007.
Pre-assignment Details  
Arm/Group Title Arm I (Cetuximab, Gemcitabine Hydrochloride, Bevacizumab) Arm II (Gemcitabine Hydrochloride, Bevacizumab, Erlotinib)
Hide Arm/Group Description Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, and 22; gemcitabine IV over 30 minutes on days 1, 8, and 15; and bevacizumab IV over 30-90 minutes on days 1 and 15. Patients receive gemcitabine and bevacizumab as in arm I. Patients also receive oral erlotinib once daily on days 1-5, 8-12, and 15-26.
Period Title: Overall Study
Started 72 71
Completed 71 68
Not Completed 1 3
Reason Not Completed
Patient deemed non eligible-never receiv             1             0
Patient withdrew and never received trea             0             2
Unknown-never received treatment             0             1
Arm/Group Title Arm I (Cetuximab, Gemcitabine Hydrochloride, Bevacizumab) Arm II (Gemcitabine Hydrochloride, Bevacizumab, Erlotinib) Total
Hide Arm/Group Description Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, and 22; gemcitabine IV over 30 minutes on days 1, 8, and 15; and bevacizumab IV over 30-90 minutes on days 1 and 15. Patients receive gemcitabine and bevacizumab as in arm I. Patients also receive oral erlotinib once daily on days 1-5, 8-12, and 15-26. Total of all reporting groups
Overall Number of Baseline Participants 71 68 139
Hide Baseline Analysis Population Description
Four patients who never received treatment are excluded.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 71 participants 68 participants 139 participants
63
(36 to 83)
63
(39 to 86)
63
(36 to 86)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 71 participants 68 participants 139 participants
Female
37
  52.1%
19
  27.9%
56
  40.3%
Male
34
  47.9%
49
  72.1%
83
  59.7%
ECOG Performance Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 71 participants 68 participants 139 participants
0 26 32 58
1 40 32 72
2 5 4 9
[1]
Measure Description:

ECOG Performance Status

The scale ranges from 0-5:

0 Fully active, without restriction

  1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature
  2. Ambulatory and capable of all selfcare but unable to carry out any work activities.
  3. Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours
  4. Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair
  5. Dead
1.Primary Outcome
Title Objective Response Rate (Complete or Partial Response) Evaluated Using the Response Evaluation Criteria in Solid Tumors (RECIST)
Hide Description [Not Specified]
Time Frame Up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Cetuximab, Gemcitabine Hydrochloride, Bevacizumab) Arm II (Gemcitabine Hydrochloride, Bevacizumab, Erlotinib)
Hide Arm/Group Description:
Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, and 22; gemcitabine IV over 30 minutes on days 1, 8, and 15; and bevacizumab IV over 30-90 minutes on days 1 and 15.
Patients receive gemcitabine and bevacizumab as in arm I. Patients also receive oral erlotinib once daily on days 1-5, 8-12, and 15-26.
Overall Number of Participants Analyzed 71 68
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
21
(12 to 32)
21
(12 to 32)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Cetuximab, Gemcitabine Hydrochloride, Bevacizumab), Arm II (Gemcitabine Hydrochloride, Bevacizumab, Erlotinib)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.22
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0
Confidence Interval (2-Sided) 95%
-13 to 14
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Progression-free Survival
Hide Description Median progression-free survival time (time from randomization to disease progression or death from any cause). Analyzed using the Kaplan-Meier (1958) estimator and their associated 95% confidence intervals determined using the method described in Brookmeyer and Crowley.
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Cetuximab, Gemcitabine Hydrochloride, Bevacizumab) Arm II (Gemcitabine Hydrochloride, Bevacizumab, Erlotinib)
Hide Arm/Group Description:
Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, and 22; gemcitabine IV over 30 minutes on days 1, 8, and 15; and bevacizumab IV over 30-90 minutes on days 1 and 15.
Patients receive gemcitabine and bevacizumab as in arm I. Patients also receive oral erlotinib once daily on days 1-5, 8-12, and 15-26.
Overall Number of Participants Analyzed 71 68
Median (95% Confidence Interval)
Unit of Measure: months
5.0
(3.7 to 5.5)
5.1
(3.2 to 5.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Cetuximab, Gemcitabine Hydrochloride, Bevacizumab), Arm II (Gemcitabine Hydrochloride, Bevacizumab, Erlotinib)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.95
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
3.Secondary Outcome
Title Overall Survival
Hide Description Time from randomization until death from any cause. Analyzed using the Kaplan-Meier (1958) estimator and their associated 5% confidence intervals determined using the method described in Brookmeyer and Crowley.
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Cetuximab, Gemcitabine Hydrochloride, Bevacizumab) Arm II (Gemcitabine Hydrochloride, Bevacizumab, Erlotinib)
Hide Arm/Group Description:
Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, and 22; gemcitabine IV over 30 minutes on days 1, 8, and 15; and bevacizumab IV over 30-90 minutes on days 1 and 15.
Patients receive gemcitabine and bevacizumab as in arm I. Patients also receive oral erlotinib once daily on days 1-5, 8-12, and 15-26.
Overall Number of Participants Analyzed 71 68
Median (95% Confidence Interval)
Unit of Measure: Months
7.9
(5.5 to 9.5)
7.1
(5.4 to 9.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Cetuximab, Gemcitabine Hydrochloride, Bevacizumab), Arm II (Gemcitabine Hydrochloride, Bevacizumab, Erlotinib)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.86
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm I (Cetuximab, Gemcitabine Hydrochloride, Bevacizumab) Arm II (Gemcitabine Hydrochloride, Bevacizumab, Erlotinib)
Hide Arm/Group Description Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, and 22; gemcitabine IV over 30 minutes on days 1, 8, and 15; and bevacizumab IV over 30-90 minutes on days 1 and 15. Patients receive gemcitabine and bevacizumab as in arm I. Patients also receive oral erlotinib once daily on days 1-5, 8-12, and 15-26.
All-Cause Mortality
Arm I (Cetuximab, Gemcitabine Hydrochloride, Bevacizumab) Arm II (Gemcitabine Hydrochloride, Bevacizumab, Erlotinib)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Arm I (Cetuximab, Gemcitabine Hydrochloride, Bevacizumab) Arm II (Gemcitabine Hydrochloride, Bevacizumab, Erlotinib)
Affected / at Risk (%) Affected / at Risk (%)
Total   21/71 (29.58%)   17/68 (25.00%) 
Blood and lymphatic system disorders     
Hemoglobin *  2/71 (2.82%)  0/68 (0.00%) 
Cardiac disorders     
Cardiac disorder *  0/71 (0.00%)  1/68 (1.47%) 
Left ventricular failure *  1/71 (1.41%)  1/68 (1.47%) 
Myocardial ischemia *  0/71 (0.00%)  1/68 (1.47%) 
Gastrointestinal disorders     
Abdominal pain *  4/71 (5.63%)  1/68 (1.47%) 
Abdominal cramping *  2/71 (2.82%)  0/68 (0.00%) 
Abdominal distension *  0/71 (0.00%)  1/68 (1.47%) 
Ascites *  1/71 (1.41%)  0/68 (0.00%) 
Diarrhea *  1/71 (1.41%)  1/68 (1.47%) 
GI bleeding *  1/71 (1.41%)  1/68 (1.47%) 
Gastrointestinal disorder *  0/71 (0.00%)  1/68 (1.47%) 
Nausea/vomiting *  1/71 (1.41%)  1/68 (1.47%) 
Obstruction gastric *  1/71 (1.41%)  1/68 (1.47%) 
Rectal hemorrhage *  1/71 (1.41%)  0/68 (0.00%) 
General disorders     
Fatigue *  1/71 (1.41%)  2/68 (2.94%) 
Hepatobiliary disorders     
Biliary obstruction *  0/71 (0.00%)  1/68 (1.47%) 
Cholecystitis NOS *  0/71 (0.00%)  1/68 (1.47%) 
Hepatobiliary disease *  2/71 (2.82%)  0/68 (0.00%) 
Hyperbilirubinemia *  1/71 (1.41%)  0/68 (0.00%) 
Infections and infestations     
Biliary tract infection *  0/71 (0.00%)  1/68 (1.47%) 
Bladder infection *  0/71 (0.00%)  1/68 (1.47%) 
Infection *  1/71 (1.41%)  1/68 (1.47%) 
Metabolism and nutrition disorders     
Alanine aminotransferase increased *  1/71 (1.41%)  0/68 (0.00%) 
Alkaline phosphatase increased *  1/71 (1.41%)  0/68 (0.00%) 
Aspartate aminotransferase increased *  0/71 (0.00%)  1/68 (1.47%) 
Dehydration *  4/71 (5.63%)  1/68 (1.47%) 
Hypermagnesemia *  1/71 (1.41%)  0/68 (0.00%) 
Hypocalcemia *  1/71 (1.41%)  0/68 (0.00%) 
Hypophosphatemia *  1/71 (1.41%)  0/68 (0.00%) 
Nervous system disorders     
Syncope/vasovagal *  0/71 (0.00%)  1/68 (1.47%) 
Psychiatric disorders     
Confusion *  0/71 (0.00%)  1/68 (1.47%) 
Mental status changes *  1/71 (1.41%)  0/68 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnea *  3/71 (4.23%)  1/68 (1.47%) 
Hypoxia *  0/71 (0.00%)  1/68 (1.47%) 
Pleural effusion *  0/71 (0.00%)  1/68 (1.47%) 
Pneumonia *  1/71 (1.41%)  0/68 (0.00%) 
Pneumothorax *  1/71 (1.41%)  0/68 (0.00%) 
Vascular disorders     
CVA *  3/71 (4.23%)  0/68 (0.00%) 
Hematoma *  1/71 (1.41%)  0/68 (0.00%) 
Hypertension *  2/71 (2.82%)  0/68 (0.00%) 
Hypotension *  0/71 (0.00%)  1/68 (1.47%) 
Thrombosis/embolism *  4/71 (5.63%)  2/68 (2.94%) 
Thrombotic microangiopathy *  0/71 (0.00%)  1/68 (1.47%) 
Vascular access complication *  2/71 (2.82%)  0/68 (0.00%) 
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm I (Cetuximab, Gemcitabine Hydrochloride, Bevacizumab) Arm II (Gemcitabine Hydrochloride, Bevacizumab, Erlotinib)
Affected / at Risk (%) Affected / at Risk (%)
Total   57/71 (80.28%)   44/68 (64.71%) 
Blood and lymphatic system disorders     
Alanine aminotransferase increased * [1]  3/71 (4.23%)  8/68 (11.76%) 
Hemoglobin * [1]  2/71 (2.82%)  6/68 (8.82%) 
Gastrointestinal disorders     
Diarrhea * [1]  2/71 (2.82%)  4/68 (5.88%) 
Nausea/vomiting * [1]  5/71 (7.04%)  6/68 (8.82%) 
General disorders     
Fatigue * [1]  11/71 (15.49%)  9/68 (13.24%) 
Investigations     
Neutropenia * [1]  18/71 (25.35%)  21/68 (30.88%) 
Platelet count decreased * [1]  10/71 (14.08%)  15/68 (22.06%) 
White blood cell count * [1]  9/71 (12.68%)  9/68 (13.24%) 
Metabolism and nutrition disorders     
Anorexia * [1]  5/71 (7.04%)  2/68 (2.94%) 
Alkaline phosphatase increased * [1]  0/71 (0.00%)  4/68 (5.88%) 
Aspartate aminotransferase increased * [1]  3/71 (4.23%)  6/68 (8.82%) 
Dehydration * [1]  2/71 (2.82%)  5/68 (7.35%) 
Renal and urinary disorders     
Proteinuria * [1]  1/71 (1.41%)  4/68 (5.88%) 
Skin and subcutaneous tissue disorders     
Rash/dermatitis * [1]  8/71 (11.27%)  3/68 (4.41%) 
Vascular disorders     
Thrombosis/embolism * [1]  5/71 (7.04%)  2/68 (2.94%) 
*
Indicates events were collected by non-systematic assessment
[1]
Worst grade 3 or higher and at least possibly related to treatment
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Hedy Kindler, MD
Organization: University of Chicago
Phone: (773) 702-0360
EMail: hkindler@medicine.bsd.uchicago.edu
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00091026     History of Changes
Other Study ID Numbers: NCI-2012-02622
NCI-2012-02622 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
NCI-6580
UCCRC-13200A
CDR0000383145
13200A ( Other Identifier: University of Chicago )
6580 ( Other Identifier: CTEP )
N01CM62204 ( U.S. NIH Grant/Contract )
N01CM62203 ( U.S. NIH Grant/Contract )
N01CM62201 ( U.S. NIH Grant/Contract )
U01CA099118 ( U.S. NIH Grant/Contract )
P30CA014599 ( U.S. NIH Grant/Contract )
First Submitted: September 7, 2004
First Posted: September 8, 2004
Results First Submitted: August 6, 2013
Results First Posted: November 20, 2013
Last Update Posted: May 15, 2014