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

Brief summary public domain (ClinicalTrials.gov)

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 public domain (ClinicalTrials.gov)

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.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Objective Response Rate (Complete or Partial Response) Evaluated Using the Response Evaluation Criteria in Solid Tumors (RECIST) [Up to 6 months]. Number, percentage of participants (95% Confidence Interval). Arm I (Cetuximab, Gemcitabine Hydrochloride, Bevacizumab) (n=71): 21 (12 to 32); Arm II (Gemcitabine Hydrochloride, Bevacizumab, Erlotinib) (n=68): 21 (12 to 32). Analysis, Arm I (Cetuximab, Gemcitabine Hydrochloride, Bevacizumab) vs Arm II (Gemcitabine Hydrochloride, Bevacizumab, Erlotinib): Risk Difference (RD) 0 (95% CI -13 to 14); p=0.22; Chi-squared; superiority or other.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Progression-free Survival [36 months]. Median, months (95% Confidence Interval). Arm I (Cetuximab, Gemcitabine Hydrochloride, Bevacizumab) (n=71): 5.0 (3.7 to 5.5); Arm II (Gemcitabine Hydrochloride, Bevacizumab, Erlotinib) (n=68): 5.1 (3.2 to 5.9). Analysis, Arm I (Cetuximab, Gemcitabine Hydrochloride, Bevacizumab) vs Arm II (Gemcitabine Hydrochloride, Bevacizumab, Erlotinib): p=0.95; Log Rank; superiority or other.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Overall Survival [36 months]. Median, Months (95% Confidence Interval). Arm I (Cetuximab, Gemcitabine Hydrochloride, Bevacizumab) (n=71): 7.9 (5.5 to 9.5); Arm II (Gemcitabine Hydrochloride, Bevacizumab, Erlotinib) (n=68): 7.1 (5.4 to 9.1). Analysis, Arm I (Cetuximab, Gemcitabine Hydrochloride, Bevacizumab) vs Arm II (Gemcitabine Hydrochloride, Bevacizumab, Erlotinib): p=0.86; Log Rank; superiority or other.