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
Overview
- Phase
- Phase 2
- Intervention
- cetuximab
- Conditions
- Adenocarcinoma of the Pancreas
- Sponsor
- National Cancer Institute (NCI)
- Enrollment
- 143
- Locations
- 1
- Primary Endpoint
- Objective Response Rate (Complete or Partial Response) Evaluated Using the Response Evaluation Criteria in Solid Tumors (RECIST)
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
This randomized phase II trial is studying bevacizumab, gemcitabine, and cetuximab to see how well they work compared to bevacizumab, gemcitabine, and erlotinib in treating patients with advanced pancreatic cancer. Monoclonal antibodies, such as cetuximab and bevacizumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Combining bevacizumab and gemcitabine with either cetuximab or erlotinib may kill more tumor cells.
Detailed Description
OBJECTIVES: 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologically or cytologically confirmed adenocarcinoma of the pancreas
- •Advanced disease
- •Patients with locally advanced disease must have disease that extends outside the boundaries of a standard radiation port
- •Not amenable to curative surgery or radiotherapy
- •Measurable disease
- •At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
- •Pleural effusions and ascites are not considered measurable lesions
- •No CNS disease, including primary brain tumors or brain metastasis
- •No tumor invasion into the duodenum
- •Performance status - ECOG 0-2
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: cetuximab
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.
Intervention: gemcitabine hydrochloride
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.
Intervention: bevacizumab
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.
Intervention: gemcitabine hydrochloride
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.
Intervention: bevacizumab
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.
Intervention: erlotinib hydrochloride
Outcomes
Primary Outcomes
Objective Response Rate (Complete or Partial Response) Evaluated Using the Response Evaluation Criteria in Solid Tumors (RECIST)
Time Frame: Up to 6 months
Secondary Outcomes
- Progression-free Survival(36 months)
- Overall Survival(36 months)