Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Phase II, Trial of Ixabepilone Plus Cetuximab as First Line Therapy for Metastatic Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00383149
Recruitment Status : Completed
First Posted : October 2, 2006
Results First Posted : October 19, 2010
Last Update Posted : March 10, 2016
Sponsor:
Information provided by (Responsible Party):
R-Pharm

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Metastatic Pancreatic Cancer
Interventions Drug: Ixabepilone
Drug: Cetuximab
Enrollment 58
Recruitment Details  
Pre-assignment Details Of the 58 participants enrolled, 4 were never treated.
Arm/Group Title Ixabepilone + Cetuximab
Hide Arm/Group Description All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
Period Title: Overall Study
Started 54
Completed 0
Not Completed 54
Reason Not Completed
Adverse Event not Related to Study Drug             3
Death             2
Disease Progression             38
Lost to Follow-up             1
Other             1
Study Drug Toxicity             4
Request to Discontinue Treatment             4
Participant Withdrew Consent             1
Arm/Group Title Ixabepilone + Cetuximab
Hide Arm/Group Description All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
Overall Number of Baseline Participants 54
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 54 participants
63.0
(47.0 to 84.0)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 54 participants
Age Greater than, equal to 65 years 22
Age less than 65 years 32
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants
Female
19
  35.2%
Male
35
  64.8%
1.Primary Outcome
Title Percentage of Participants Surviving at 6 Months
Hide Description The percentage of participants surviving at 6 months was defined as the number of treated participants who had not died prior to 6 months from the date of their first dose divided by the total number of treated participants.
Time Frame From time of first dose of study drug through 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants; all participants who received at least one dose of ixabepilone or cetuximab. Participants who did not die prior to 6 months but dropped out of the study were not included in the numerator.
Arm/Group Title Ixabepilone + Cetuximab
Hide Arm/Group Description:
All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
Overall Number of Participants Analyzed 54
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
57.4
(43.2 to 70.8)
2.Secondary Outcome
Title Best Overall Tumor Response
Hide Description Tumor response was assessed according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR)= disappearance of all non-target lesions, Partial Response (PR)= at least 30% reduction in the sum of the longest diameter (LD) of all target lesions in reference to the baseline sum LD; Stable Disease (SD)= neither PR nor progressive disease (PD) criteria were met; PD = at least 20% increase in the sum of the LD of all target lesions, taking as reference the smallest sum LD recorded at or following baseline.
Time Frame From time of first dose of study until 16.49 months (longest period for participant between first dose and documented disease progression)
Hide Outcome Measure Data
Hide Analysis Population Description
Response-evaluable participants; all participants with measurable disease who received at least one dose of ixabepilone or cetuximab and who had at least one on-treatment tumor assessment.
Arm/Group Title Ixabepilone + Cetuximab
Hide Arm/Group Description:
All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
Overall Number of Participants Analyzed 31
Measure Type: Number
Unit of Measure: participants
Participants with Complete Response 0
Participants with Partial Response 4
Participants with Stable Disease 24
Participants with Progressive Disease 2
Participants with Response Unable to be Determined 1
3.Secondary Outcome
Title Percentage of Participants With Objective Tumor Response
Hide Description Percentage of participants with objective tumor response was determined by the number of participants with PR or CR divided by the total number of response-evaluable participants. Tumor response was assessed according RECIST criteria: PR=at least 30% reduction in the sum of the LD of all target lesions in reference to the baseline sum LD, CR=Disappearance of all non-target lesions.
Time Frame From time of first dose of study until 16.49 months (longest period for participant between first dose and documented disease progression
Hide Outcome Measure Data
Hide Analysis Population Description
Response-evaluable participants; all participants with measurable disease who received at least one dose of ixabepilone or cetuximab and who had at least one on-treatment tumor assessment.
Arm/Group Title Ixabepilone + Cetuximab
Hide Arm/Group Description:
All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
Overall Number of Participants Analyzed 31
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
12.9
(3.6 to 29.8)
4.Secondary Outcome
Title Median Progression Free Survival Time
Hide Description Progression-Free Survival (PFS) time was defined as the time, in months, from the first dosing date until the date of disease progression or death from any cause.
Time Frame From time of first dose of study until 16.49 months (longest period for participant between first dose and documented disease progression
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants; all participants who received at least one dose of ixabepilone or cetuximab. Participants without disease progression or death were censored at the last tumor assessment.
Arm/Group Title Ixabepilone + Cetuximab
Hide Arm/Group Description:
All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
Overall Number of Participants Analyzed 54
Median (95% Confidence Interval)
Unit of Measure: months
3.9
(2.6 to 4.4)
5.Secondary Outcome
Title Median Overall Survival Time
Hide Description Overall survival time was defined as the time in months from the first dosing date to the date of death.
Time Frame From the first dosing date until death (last reported death was 21 months after first dose).
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants; all participants who received at least one dose of ixabepilone or cetuximab. Participants without a reported date of death were censored at the last known alive date.
Arm/Group Title Ixabepilone + Cetuximab
Hide Arm/Group Description:
All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
Overall Number of Participants Analyzed 54
Median (95% Confidence Interval)
Unit of Measure: months
7.6
(5.5 to 12.2)
6.Secondary Outcome
Title Median Duration of Response
Hide Description Duration of response was defined as the number of months from when measurement criteria were first met for CR or PR (whichever was recorded first) until the first date of disease progression or death. Complete Response (CR)= disappearance of all non-target lesions, Partial Response (PR)= at least 30% reduction in the sum of the longest diameter (LD) of all target lesions in reference to the baseline sum LD.
Time Frame From first date recorded for CR or PR until the first date of disease progression or death (last participant with tumor response progressed 6.5 months after documented response).
Hide Outcome Measure Data
Hide Analysis Population Description
Response-evaluable participants whose best response was PR or CR. Participants without disease progression or death were censored at the last tumor assessment date.
Arm/Group Title Ixabepilone + Cetuximab
Hide Arm/Group Description:
All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
Overall Number of Participants Analyzed 4
Median (95% Confidence Interval)
Unit of Measure: months
5.7
(2.8 to 6.3)
7.Secondary Outcome
Title Median Time to Response
Hide Description Time to response was defined as the number of weeks from first dose of study therapy (ixabepilone or cetuximab) until measurement criteria were first met for PR or CR, whichever status was recorded first. Complete Response (CR)= disappearance of all non-target lesions, Partial Response (PR)= at least 30% reduction in the sum of the longest diameter (LD) of all target lesions in reference to the baseline sum LD.
Time Frame Time from first dose of study therapy until first date of PR or CR. Maximum time to response was 19 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Response-evaluable participants whose best response was PR or CR.
Arm/Group Title Ixabepilone + Cetuximab
Hide Arm/Group Description:
All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
Overall Number of Participants Analyzed 4
Median (Full Range)
Unit of Measure: weeks
8.8
(5.1 to 19.0)
8.Secondary Outcome
Title Number of Participants With Death Within 30 Days of Last Dose, Any Serious Adverse Event (SAE), Any Adverse Event (AE) Leading to Discontinuation (DC), or Any Treatment-related AEs By Common Terminology Criteria Version 3.0 (CTC v3) Grade (Gr)
Hide Description AE=any new untoward medical occurrence or worsening of a pre-existing medical condition not necessarily having a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization/causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, or is an important medical event.
Time Frame From the time of first dose of study drug to ≤30 days after the end of the last dose of study drug or until resolution of study drug-related toxicity.
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants; all participants who received at least one dose of ixabepilone or cetuximab. The 53 participants reporting treatment-related AEs included 1 additional participant who also developed Grade 5 viscous intestinal perforation, which was also captured under death within 30 days of last dose category.
Arm/Group Title Ixabepilone + Cetuximab
Hide Arm/Group Description:
All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
Overall Number of Participants Analyzed 54
Measure Type: Number
Unit of Measure: participants
All deaths within 30 days of last dose 7
Any SAE 32
Gr 2 (moderate) AE leading to DC 2
Gr 3 (severe) AE leading to DC 9
Gr 4 (life-threatening) AE leading to DC 3
All AEs leading to DC 14
Gr 1 (mild) treatment-related AE 4
Gr 2 (moderate) treatment-related AE 13
Gr 3 (severe) treatment-related AE 25
Gr 4 (life-threatening) treatment-related AE 10
Gr 5 (death) treatment-related AE 1
All treatment-related AEs 53
9.Secondary Outcome
Title Number of Participants With Most Common Treatment-related Nonhematologic AE (>25%) By CTC v3 Grade (Gr)
Hide Description AE=any new untoward medical occurrence or worsening of a pre-existing medical condition not necessarily having a causal relationship with this treatment. Acneform rash and peripheral neuropathy were captured by multiple MedDRA preferred terms. Acneform rash included rash, rash pustular, and rash pruritic preferred terms. Peripheral neuropathy included neuromuscular toxicity, peripheral motor neuropathy, and peripheral sensorimotor neuropathy preferred terms.
Time Frame From the time of first dose of study drug to ≤30 days after the end of the last dose of study drug or until resolution of study drug-related toxicity.
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants; all participants who received at least one dose of ixabepilone or cetuximab.
Arm/Group Title Ixabepilone + Cetuximab
Hide Arm/Group Description:
All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
Overall Number of Participants Analyzed 54
Measure Type: Number
Unit of Measure: participants
Gr 1 (mild) acneform rash 21
Gr 2 (moderate) acneform rash 13
Gr 3 (severe) acneform rash 1
All acneform rash 35
Gr 1 (mild) fatigue 8
Gr 2 (moderate) fatigue 13
Gr 3 (severe) fatigue 8
Gr 4 (life-threatening) fatigue 1
All fatigue 30
Gr 1 (mild) alopecia 13
Gr 2 (moderate) alopecia 12
All alopecia 25
Gr 1 (mild) nausea 13
Gr 2 (moderate) nausea 6
Gr 3 (severe) nausea 3
All nausea 22
Gr 1 (mild) diarrhea 11
Gr 2 (moderate) diarrhea 4
Gr 3 (severe) diarrhea 1
Gr 4 (life-threatening) diarrhea 2
All diarrhea 18
Gr 1 (mild) vomiting 12
Gr 2 (moderate) vomiting 2
Gr 3 (severe) vomiting 3
All vomiting 17
Gr 1 (mild) peripheral neuropathy 12
Gr 2 (moderate) peripheral neuropathy 1
Gr 3 (severe) peripheral neuropathy 3
All peripheral neuropathy 16
Gr 1 (mild) hypomagnesemia 7
Gr 2 (moderate) hypomagnesemia 4
Gr 3 (severe) hypomagnesemia 1
Gr 4 (life-threatening) hypomagnesemia 3
All hypomagnesemia 15
10.Secondary Outcome
Title Number of Participants With Hematology, Liver Function, and Renal Laboratory Abnormalities By CTC v3 Grade (Gr)
Hide Description Laboratory results were graded according to CTC v 3.0. Hematology laboratory evaluations included absolute neutrophil count (ANC), white blood cell count (WBC), platelets (PLT), and hemoglobin (HGB). Liver function laboratory evaluations included alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, and total bilirubin. Renal function laboratory evaluation included creatinine.
Time Frame From the time of first dose of study drug to ≤30 days after the end of the last dose of study drug or until resolution of study drug-related toxicity.
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants; all participants who received at least one dose of ixabepilone or cetuximab. n= number of participants with laboratory data available
Arm/Group Title Ixabepilone + Cetuximab
Hide Arm/Group Description:
All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
Overall Number of Participants Analyzed 54
Measure Type: Number
Unit of Measure: participants
Gr 0 (no abnormality) WBC, n=51 12
Gr 1 (mild) WBC, n=51 9
Gr 2 (moderate) WBC, n=51 9
Gr 3 (severe) WBC, n=51 17
Gr 4 (life-threatening) WBC, n=51 4
Gr 1-4 WBC, n=51 39
Gr 3-4 WBC, n=51 21
Gr 0 (no abnormality) ANC, n=50 12
Gr 1 (mild) ANC, n=50 8
Gr 2 (moderate) ANC, n=50 12
Gr 3 (severe) ANC, n=50 10
Gr 4 (life-threatening) ANC, n=50 8
Gr 1-4 ANC, n=50 38
Gr 3-4 ANC, n=51 18
Gr 0 (no abnormality) platelet count, n=51 29
Gr 1 (mild) platelet count, n=51 18
Gr 2 (moderate) platelet count, n=51 4
Gr 1-4 platelet count, n=51 2
Gr 0 (no abnormality) HGB, n=51 3
Gr 1 (mild) HGB, n=51 28
Gr 2 (moderate) HGB, n=51 18
Gr 3 (severe) HGB, n=51 2
Gr 1-4 HGB, n=51 48
Gr 3-4 HGB, n=51 2
Gr 0 (no abnormality) ALT, n=46 31
Gr 1 (mild) ALT, n=46 10
Gr 2 (moderate) ALT, n=46 3
Gr 3 (severe) ALT, n=46 2
Gr 1-4 ALT, n=46 15
Gr 3-4 ALT, n=46 2
Gr 0 (no abnormality) AST, n=47 28
Gr 1 (mild) AST, n=47 17
Gr 3 (severe) AST, n=47 2
Gr 1-4 AST, n=47 19
Gr 3-4 AST, n=47 2
Gr 0 (no abnormality) alkaline phosphatase, n=47 18
Gr 1 (mild) alkaline phosphatase, n=47 20
Gr 2 (moderate) alkaline phosphatase, n=47 5
Gr 3 (severe) alkaline phosphatase, n=47 4
Gr 1-4 alkaline phosphatase, n=47 29
Gr 3-4 alkaline phosphatase, n=47 4
Gr 0 (no abnormality) total bilirubin, n=48 42
Gr 1 (mild) total bilirubin, n=48 1
Gr 2 (moderate) total bilirubin, n=48 1
Gr 3 (severe) total bilirubin, n=48 4
Gr 1-4 total bilirubin, n=48 6
Gr 3-4 total bilirubin, n=48 4
Gr 0 (no abnormality) creatinine, n=48 45
Gr 1 (mild) creatinine, n=48 3
Gr 1-4 creatinine, n=48 3
11.Secondary Outcome
Title Number of Participants With Dose Reduction, Dose Delay, or Dose Interruption
Hide Description Dose reduction of ixabepilone and/or cetuximab due to toxicity was permitted for participants deriving benefit from therapy. Each drug could be dose modified independently of the others. Participants unable to start a cycle due to unacceptable toxicity related to ixabepilone or cetuximab could have therapy delayed for up to 4 weeks. If toxicities prevented the administration of ixabepilone or cetuximab therapy, participants continued receiving the other therapy as scheduled. A dose interruption for ixabepilone or cetuximab was defined as any interruption during the infusion period.
Time Frame From the first dosing date of Cycle 1 until the last dosing date of the last cycle. Last dosing cycle for a participant was Cycle 21.
Hide Outcome Measure Data
Hide Analysis Population Description
Since the combination of ixabepilone and cetuximab tested in this trial failed to meet the primary objective of sufficiently improving 6-month survival rate relative to historical control in participants with metastatic pancreatic cancer, dose modification data were collected but not summarized.
Arm/Group Title Ixabepilone Cetuximab
Hide Arm/Group Description:
All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks.
All participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Percentage of Participants With Baseline Epidermal Growth Factor Receptor (EGFR) Tumor Expression
Hide Description EGFR expression was evaluated by means of an immunohistochemical assay using tumor tissue collected prior to receiving first dose.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Tissue was available for a small proportion of patients and only 1 out of 11 was EGFR positive, hence EFGR expression analysis was not performed.
Arm/Group Title Ixabepilone + Cetuximab
Hide Arm/Group Description:
All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
13.Secondary Outcome
Title Change From Baseline in FHSI-8 Total Score by Time-point
Hide Description The FHSI-8 includes eight items representing pancreatic-related symptoms; each symptom is rated by participants on a scale of from 0 to 4. The FHSI-8 total score ranges in value from 0 to 32, with higher scores representing fewer symptoms and lower scores representing more symptoms. Scoring of the FHSI-8 was to be conducted according to the Functional Assessment of Chronic Illness Therapy (FACIT) manual. The symptom assessment was to include treated participants who had baseline measurement and at least one on-study measurement of FHSI-8 questionnaire.
Time Frame Baseline, Week 3, Week 6, Week 9, Week 12, Week 12, Week 18, Week 24 and every 3 weeks through end of study (participant death/withdrawal from study)
Hide Outcome Measure Data
Hide Analysis Population Description
Since the combination of ixabepilone and cetuximab tested in this trial failed to meet the primary objective of sufficiently improving 6-month survival rate relative to historical control in participants with metastatic pancreatic cancer, FHSI-8 score data were collected but not summarized.
Arm/Group Title Ixabepilone + Cetuximab
Hide Arm/Group Description:
All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ixabepilone + Cetuximab
Hide Arm/Group Description All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
All-Cause Mortality
Ixabepilone + Cetuximab
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Ixabepilone + Cetuximab
Affected / at Risk (%)
Total   32/54 (59.26%) 
Blood and lymphatic system disorders   
LEUKOPENIA  1  1/54 (1.85%) 
NEUTROPENIA  1  2/54 (3.70%) 
LEUKOCYTOSIS  1  1/54 (1.85%) 
FEBRILE NEUTROPENIA  1  2/54 (3.70%) 
Cardiac disorders   
ATRIAL FIBRILLATION  1  2/54 (3.70%) 
LEFT VENTRICULAR DYSFUNCTION  1  1/54 (1.85%) 
Gastrointestinal disorders   
NAUSEA  1  3/54 (5.56%) 
ASCITES  1  1/54 (1.85%) 
VOMITING  1  4/54 (7.41%) 
DIARRHOEA  1  2/54 (3.70%) 
STOMATITIS  1  1/54 (1.85%) 
PANCREATITIS  1  1/54 (1.85%) 
HAEMATOCHEZIA  1  1/54 (1.85%) 
ABDOMINAL MASS  1  1/54 (1.85%) 
ABDOMINAL PAIN  1  2/54 (3.70%) 
INTESTINAL PERFORATION  1  1/54 (1.85%) 
General disorders   
CHILLS  1  1/54 (1.85%) 
PYREXIA  1  3/54 (5.56%) 
VISCERAL OEDEMA  1  1/54 (1.85%) 
MULTI-ORGAN FAILURE  1  1/54 (1.85%) 
Hepatobiliary disorders   
CHOLANGITIS  1  1/54 (1.85%) 
HYPERBILIRUBINAEMIA  1  1/54 (1.85%) 
Immune system disorders   
HYPERSENSITIVITY  1  3/54 (5.56%) 
ANAPHYLACTIC REACTION  1  1/54 (1.85%) 
Infections and infestations   
INFECTION  1  1/54 (1.85%) 
PNEUMONIA  1  1/54 (1.85%) 
BACTERAEMIA  1  1/54 (1.85%) 
SEPTIC SHOCK  1  1/54 (1.85%) 
LIVER ABSCESS  1  1/54 (1.85%) 
PYELONEPHRITIS  1  1/54 (1.85%) 
ESCHERICHIA BACTERAEMIA  1  1/54 (1.85%) 
Investigations   
WEIGHT DECREASED  1  1/54 (1.85%) 
INTERNATIONAL NORMALISED RATIO INCREASED  1  1/54 (1.85%) 
Metabolism and nutrition disorders   
DEHYDRATION  1  5/54 (9.26%) 
HYPOMAGNESAEMIA  1  2/54 (3.70%) 
Musculoskeletal and connective tissue disorders   
MYALGIA  1  1/54 (1.85%) 
BACK PAIN  1  2/54 (3.70%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
PANCREATIC CARCINOMA  1  6/54 (11.11%) 
Nervous system disorders   
SYNCOPE  1  1/54 (1.85%) 
HEADACHE  1  1/54 (1.85%) 
PARAESTHESIA  1  1/54 (1.85%) 
Psychiatric disorders   
CONFUSIONAL STATE  1  1/54 (1.85%) 
MENTAL STATUS CHANGES  1  1/54 (1.85%) 
Renal and urinary disorders   
RENAL FAILURE  1  1/54 (1.85%) 
Respiratory, thoracic and mediastinal disorders   
HYPOXIA  1  1/54 (1.85%) 
DYSPNOEA  1  2/54 (3.70%) 
PULMONARY EMBOLISM  1  2/54 (3.70%) 
RESPIRATORY FAILURE  1  1/54 (1.85%) 
Vascular disorders   
HYPOTENSION  1  6/54 (11.11%) 
DEEP VEIN THROMBOSIS  1  2/54 (3.70%) 
ORTHOSTATIC HYPOTENSION  1  1/54 (1.85%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ixabepilone + Cetuximab
Affected / at Risk (%)
Total   49/54 (90.74%) 
Blood and lymphatic system disorders   
ANAEMIA  1  14/54 (25.93%) 
LEUKOPENIA  1  8/54 (14.81%) 
LYMPHOPENIA  1  4/54 (7.41%) 
NEUTROPENIA  1  11/54 (20.37%) 
THROMBOCYTOPENIA  1  3/54 (5.56%) 
Gastrointestinal disorders   
NAUSEA  1  25/54 (46.30%) 
ASCITES  1  6/54 (11.11%) 
VOMITING  1  18/54 (33.33%) 
DIARRHOEA  1  22/54 (40.74%) 
FLATULENCE  1  8/54 (14.81%) 
STOMATITIS  1  8/54 (14.81%) 
CONSTIPATION  1  20/54 (37.04%) 
ABDOMINAL PAIN  1  17/54 (31.48%) 
ABDOMINAL DISCOMFORT  1  3/54 (5.56%) 
ABDOMINAL DISTENSION  1  4/54 (7.41%) 
ABDOMINAL PAIN UPPER  1  4/54 (7.41%) 
General disorders   
CHILLS  1  3/54 (5.56%) 
FATIGUE  1  34/54 (62.96%) 
PYREXIA  1  9/54 (16.67%) 
ASTHENIA  1  5/54 (9.26%) 
OEDEMA PERIPHERAL  1  7/54 (12.96%) 
MUCOSAL INFLAMMATION  1  9/54 (16.67%) 
Immune system disorders   
HYPERSENSITIVITY  1  5/54 (9.26%) 
Infections and infestations   
PARONYCHIA  1  4/54 (7.41%) 
URINARY TRACT INFECTION  1  4/54 (7.41%) 
Investigations   
WEIGHT DECREASED  1  11/54 (20.37%) 
ALANINE AMINOTRANSFERASE INCREASED  1  4/54 (7.41%) 
ASPARTATE AMINOTRANSFERASE INCREASED  1  4/54 (7.41%) 
BLOOD ALKALINE PHOSPHATASE INCREASED  1  6/54 (11.11%) 
Metabolism and nutrition disorders   
ANOREXIA  1  17/54 (31.48%) 
DEHYDRATION  1  7/54 (12.96%) 
HYPOKALAEMIA  1  4/54 (7.41%) 
HYPERKALAEMIA  1  3/54 (5.56%) 
HYPERGLYCAEMIA  1  3/54 (5.56%) 
HYPOMAGNESAEMIA  1  17/54 (31.48%) 
Musculoskeletal and connective tissue disorders   
MYALGIA  1  3/54 (5.56%) 
BACK PAIN  1  9/54 (16.67%) 
PAIN IN EXTREMITY  1  4/54 (7.41%) 
MUSCULOSKELETAL PAIN  1  3/54 (5.56%) 
Nervous system disorders   
HEADACHE  1  5/54 (9.26%) 
DIZZINESS  1  9/54 (16.67%) 
DYSGEUSIA  1  3/54 (5.56%) 
PARAESTHESIA  1  5/54 (9.26%) 
NEUROPATHY PERIPHERAL  1  4/54 (7.41%) 
PERIPHERAL SENSORY NEUROPATHY  1  6/54 (11.11%) 
Psychiatric disorders   
ANXIETY  1  6/54 (11.11%) 
INSOMNIA  1  9/54 (16.67%) 
DEPRESSION  1  6/54 (11.11%) 
Renal and urinary disorders   
DYSURIA  1  4/54 (7.41%) 
Respiratory, thoracic and mediastinal disorders   
COUGH  1  6/54 (11.11%) 
DYSPNOEA  1  8/54 (14.81%) 
EPISTAXIS  1  4/54 (7.41%) 
OROPHARYNGEAL PAIN  1  3/54 (5.56%) 
Skin and subcutaneous tissue disorders   
RASH  1  5/54 (9.26%) 
ALOPECIA  1  25/54 (46.30%) 
DRY SKIN  1  7/54 (12.96%) 
PRURITUS  1  4/54 (7.41%) 
DERMATITIS ACNEIFORM  1  29/54 (53.70%) 
Vascular disorders   
HYPOTENSION  1  8/54 (14.81%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Study CA163-116 was completed; however, the combination tested in this trial failed to meet the primary objective to demonstrate a 6-month survival rate greater than 50% in participants with metastatic pancreatic cancer.
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.
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Name/Official Title: BMS Study Director
Organization: Organization: Bristol-Myers Squibb
EMail: Clinical.Trials@bms.com
Layout table for additonal information
Responsible Party: R-Pharm
ClinicalTrials.gov Identifier: NCT00383149     History of Changes
Other Study ID Numbers: CA163-116
First Submitted: September 28, 2006
First Posted: October 2, 2006
Results First Submitted: September 24, 2010
Results First Posted: October 19, 2010
Last Update Posted: March 10, 2016