Bevacizumab and Gemcitabine Combined With Either Cetuximab or Erlotinib in Treating Patients With Advanced Pancreatic Cancer
|ClinicalTrials.gov Identifier: NCT00091026|
Recruitment Status : Completed
First Posted : September 8, 2004
Results First Posted : November 20, 2013
Last Update Posted : May 15, 2014
|Condition or disease||Intervention/treatment||Phase|
|Adenocarcinoma of the Pancreas Recurrent Pancreatic Cancer Stage II Pancreatic Cancer Stage III Pancreatic Cancer Stage IV Pancreatic Cancer||Biological: cetuximab Drug: gemcitabine hydrochloride Biological: bevacizumab Drug: erlotinib hydrochloride||Phase 2|
I. Compare the objective response rate in patients with advanced adenocarcinoma of the pancreas treated with bevacizumab and gemcitabine with cetuximab vs erlotinib.
II. Compare the toxicity of these regimens in these patients. III. Compare median progression-free and overall survival of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center (University of Chicago vs other) and ECOG performance status (0-1 vs 2). Patients are randomized to 1 of 2 treatment arms.
Arm I: 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: 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.
In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 54-126 patients (27-63 per treatment arm) will be accrued for this study within 16 months.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||143 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Phase II Study of Bevacizumab (NSC# 704865) and Gemcitabine in Combination With Either Cetuximab (NSC# 714692) or OSI-774 (NSC# 718781) in Patients With Advanced Pancreatic Cancer|
|Study Start Date :||July 2004|
|Primary Completion Date :||January 2011|
|Study Completion Date :||January 2011|
Experimental: 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.
Other Names:Drug: gemcitabine hydrochloride
Other Names:Biological: bevacizumab
Experimental: 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.
Drug: gemcitabine hydrochloride
Other Names:Biological: bevacizumab
Other Names:Drug: erlotinib hydrochloride
- Objective Response Rate (Complete or Partial Response) Evaluated Using the Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Up to 6 months ]
- Progression-free Survival [ Time Frame: 36 months ]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.
- Overall Survival [ Time Frame: 36 months ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00091026
|United States, Illinois|
|University of Chicago|
|Chicago, Illinois, United States, 60637|
|Principal Investigator:||Hedy Kindler||University of Chicago|