Trial Outcomes & Findings for Bevacizumab and Gemcitabine Combined With Either Cetuximab or Erlotinib in Treating Patients With Advanced Pancreatic Cancer (NCT NCT00091026)
NCT ID: NCT00091026
Last Updated: 2014-05-15
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
143 participants
Primary outcome timeframe
Up to 6 months
Results posted on
2014-05-15
Participant Flow
Patients were enrolled at sixteen sites between September 2004 and February 2007.
Participant milestones
| Measure |
Arm I (Cetuximab, Gemcitabine Hydrochloride, Bevacizumab)
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.
|
Arm II (Gemcitabine Hydrochloride, Bevacizumab, Erlotinib)
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 Study
STARTED
|
72
|
71
|
|
Overall Study
COMPLETED
|
71
|
68
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
Arm I (Cetuximab, Gemcitabine Hydrochloride, Bevacizumab)
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.
|
Arm II (Gemcitabine Hydrochloride, Bevacizumab, Erlotinib)
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 Study
Patient deemed non eligible-never receiv
|
1
|
0
|
|
Overall Study
Patient withdrew and never received trea
|
0
|
2
|
|
Overall Study
Unknown-never received treatment
|
0
|
1
|
Baseline Characteristics
Bevacizumab and Gemcitabine Combined With Either Cetuximab or Erlotinib in Treating Patients With Advanced Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
Arm I (Cetuximab, Gemcitabine Hydrochloride, Bevacizumab)
n=71 Participants
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.
|
Arm II (Gemcitabine Hydrochloride, Bevacizumab, Erlotinib)
n=68 Participants
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
n=139 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63 years
n=5 Participants
|
63 years
n=7 Participants
|
63 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
|
ECOG Performance Status
0
|
26 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
ECOG Performance Status
1
|
40 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
ECOG Performance Status
2
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 6 monthsOutcome measures
| Measure |
Arm I (Cetuximab, Gemcitabine Hydrochloride, Bevacizumab)
n=71 Participants
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.
|
Arm II (Gemcitabine Hydrochloride, Bevacizumab, Erlotinib)
n=68 Participants
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.
|
|---|---|---|
|
Objective Response Rate (Complete or Partial Response) Evaluated Using the Response Evaluation Criteria in Solid Tumors (RECIST)
|
21 percentage of participants
Interval 12.0 to 32.0
|
21 percentage of participants
Interval 12.0 to 32.0
|
SECONDARY outcome
Timeframe: 36 monthsMedian 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.
Outcome measures
| Measure |
Arm I (Cetuximab, Gemcitabine Hydrochloride, Bevacizumab)
n=71 Participants
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.
|
Arm II (Gemcitabine Hydrochloride, Bevacizumab, Erlotinib)
n=68 Participants
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.
|
|---|---|---|
|
Progression-free Survival
|
5.0 months
Interval 3.7 to 5.5
|
5.1 months
Interval 3.2 to 5.9
|
SECONDARY outcome
Timeframe: 36 monthsTime 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.
Outcome measures
| Measure |
Arm I (Cetuximab, Gemcitabine Hydrochloride, Bevacizumab)
n=71 Participants
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.
|
Arm II (Gemcitabine Hydrochloride, Bevacizumab, Erlotinib)
n=68 Participants
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 Survival
|
7.9 Months
Interval 5.5 to 9.5
|
7.1 Months
Interval 5.4 to 9.1
|
Adverse Events
Arm I (Cetuximab, Gemcitabine Hydrochloride, Bevacizumab)
Serious events: 21 serious events
Other events: 57 other events
Deaths: 0 deaths
Arm II (Gemcitabine Hydrochloride, Bevacizumab, Erlotinib)
Serious events: 17 serious events
Other events: 44 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I (Cetuximab, Gemcitabine Hydrochloride, Bevacizumab)
n=71 participants at risk
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.
|
Arm II (Gemcitabine Hydrochloride, Bevacizumab, Erlotinib)
n=68 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
5.6%
4/71
|
1.5%
1/68
|
|
Gastrointestinal disorders
Abdominal cramping
|
2.8%
2/71
|
0.00%
0/68
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/71
|
1.5%
1/68
|
|
Metabolism and nutrition disorders
Alanine aminotransferase increased
|
1.4%
1/71
|
0.00%
0/68
|
|
Metabolism and nutrition disorders
Alkaline phosphatase increased
|
1.4%
1/71
|
0.00%
0/68
|
|
Gastrointestinal disorders
Ascites
|
1.4%
1/71
|
0.00%
0/68
|
|
Metabolism and nutrition disorders
Aspartate aminotransferase increased
|
0.00%
0/71
|
1.5%
1/68
|
|
Hepatobiliary disorders
Biliary obstruction
|
0.00%
0/71
|
1.5%
1/68
|
|
Infections and infestations
Biliary tract infection
|
0.00%
0/71
|
1.5%
1/68
|
|
Infections and infestations
Bladder infection
|
0.00%
0/71
|
1.5%
1/68
|
|
Cardiac disorders
Cardiac disorder
|
0.00%
0/71
|
1.5%
1/68
|
|
Vascular disorders
CVA
|
4.2%
3/71
|
0.00%
0/68
|
|
Hepatobiliary disorders
Cholecystitis NOS
|
0.00%
0/71
|
1.5%
1/68
|
|
Psychiatric disorders
Confusion
|
0.00%
0/71
|
1.5%
1/68
|
|
Metabolism and nutrition disorders
Dehydration
|
5.6%
4/71
|
1.5%
1/68
|
|
Gastrointestinal disorders
Diarrhea
|
1.4%
1/71
|
1.5%
1/68
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.2%
3/71
|
1.5%
1/68
|
|
General disorders
Fatigue
|
1.4%
1/71
|
2.9%
2/68
|
|
Gastrointestinal disorders
GI bleeding
|
1.4%
1/71
|
1.5%
1/68
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/71
|
1.5%
1/68
|
|
Vascular disorders
Hematoma
|
1.4%
1/71
|
0.00%
0/68
|
|
Blood and lymphatic system disorders
Hemoglobin
|
2.8%
2/71
|
0.00%
0/68
|
|
Hepatobiliary disorders
Hepatobiliary disease
|
2.8%
2/71
|
0.00%
0/68
|
|
Hepatobiliary disorders
Hyperbilirubinemia
|
1.4%
1/71
|
0.00%
0/68
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
1.4%
1/71
|
0.00%
0/68
|
|
Vascular disorders
Hypertension
|
2.8%
2/71
|
0.00%
0/68
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
1.4%
1/71
|
0.00%
0/68
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
1.4%
1/71
|
0.00%
0/68
|
|
Vascular disorders
Hypotension
|
0.00%
0/71
|
1.5%
1/68
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/71
|
1.5%
1/68
|
|
Infections and infestations
Infection
|
1.4%
1/71
|
1.5%
1/68
|
|
Cardiac disorders
Left ventricular failure
|
1.4%
1/71
|
1.5%
1/68
|
|
Psychiatric disorders
Mental status changes
|
1.4%
1/71
|
0.00%
0/68
|
|
Cardiac disorders
Myocardial ischemia
|
0.00%
0/71
|
1.5%
1/68
|
|
Gastrointestinal disorders
Nausea/vomiting
|
1.4%
1/71
|
1.5%
1/68
|
|
Gastrointestinal disorders
Obstruction gastric
|
1.4%
1/71
|
1.5%
1/68
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/71
|
1.5%
1/68
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
1.4%
1/71
|
0.00%
0/68
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.4%
1/71
|
0.00%
0/68
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
1.4%
1/71
|
0.00%
0/68
|
|
Nervous system disorders
Syncope/vasovagal
|
0.00%
0/71
|
1.5%
1/68
|
|
Vascular disorders
Thrombosis/embolism
|
5.6%
4/71
|
2.9%
2/68
|
|
Vascular disorders
Thrombotic microangiopathy
|
0.00%
0/71
|
1.5%
1/68
|
|
Vascular disorders
Vascular access complication
|
2.8%
2/71
|
0.00%
0/68
|
Other adverse events
| Measure |
Arm I (Cetuximab, Gemcitabine Hydrochloride, Bevacizumab)
n=71 participants at risk
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.
|
Arm II (Gemcitabine Hydrochloride, Bevacizumab, Erlotinib)
n=68 participants at risk
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.
|
|---|---|---|
|
Metabolism and nutrition disorders
Anorexia
|
7.0%
5/71
|
2.9%
2/68
|
|
Blood and lymphatic system disorders
Alanine aminotransferase increased
|
4.2%
3/71
|
11.8%
8/68
|
|
Metabolism and nutrition disorders
Alkaline phosphatase increased
|
0.00%
0/71
|
5.9%
4/68
|
|
Metabolism and nutrition disorders
Aspartate aminotransferase increased
|
4.2%
3/71
|
8.8%
6/68
|
|
Metabolism and nutrition disorders
Dehydration
|
2.8%
2/71
|
7.4%
5/68
|
|
Gastrointestinal disorders
Diarrhea
|
2.8%
2/71
|
5.9%
4/68
|
|
General disorders
Fatigue
|
15.5%
11/71
|
13.2%
9/68
|
|
Blood and lymphatic system disorders
Hemoglobin
|
2.8%
2/71
|
8.8%
6/68
|
|
Gastrointestinal disorders
Nausea/vomiting
|
7.0%
5/71
|
8.8%
6/68
|
|
Investigations
Neutropenia
|
25.4%
18/71
|
30.9%
21/68
|
|
Investigations
Platelet count decreased
|
14.1%
10/71
|
22.1%
15/68
|
|
Renal and urinary disorders
Proteinuria
|
1.4%
1/71
|
5.9%
4/68
|
|
Skin and subcutaneous tissue disorders
Rash/dermatitis
|
11.3%
8/71
|
4.4%
3/68
|
|
Vascular disorders
Thrombosis/embolism
|
7.0%
5/71
|
2.9%
2/68
|
|
Investigations
White blood cell count
|
12.7%
9/71
|
13.2%
9/68
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60