Recurrent Rectal Cancer Clinical Trial
Official title:
A Randomized Phase II Study of Bevacizumab in Combination With Cetuximab Plus Irinotecan, or in Combination With Cetuximab Alone, in Irinotecan-Refractory Colorectal Cancer
This randomized phase II trial is studying giving bevacizumab and cetuximab together with irinotecan to see how well it works compared to giving bevacizumab and cetuximab alone in treating patients with irinotecan-refractory metastatic colorectal cancer. Monoclonal antibodies such as cetuximab and bevacizumab can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or deliver tumor -killing substances to them. Drugs used in chemotherapy, such as irinotecan, also work in different ways to kill tumor cells or stop them from growing. Giving cetuximab and bevacizumab together with irinotecan may improve the ability to block tumor growth.
PRIMARY OBJECTIVES:
I. Evaluate time to tumor progression in patients with irinotecan-refractory metastatic
colorectal cancer treated with bevacizumab and cetuximab with or without irinotecan.
II. Evaluate objective response rate in patients treated with these regimens. III. Evaluate
overall survival of patients treated with these regimens. IV. Evaluate safety, tolerability,
and adverse event profiles of these regimens in these patients.
V. Correlate a panel of molecular markers (e.g., those involved in the epidermal growth
factor receptor signaling pathway, angiogenic pathway, and irinotecan metabolism) with
clinical outcome in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
participating center, ECOG performance status (0 vs 1), and albumin (> 3.0 g/dL vs ≤ 3.0
g/dL). Patients are randomized to 1 of 2 treatment arms.
ARM A: Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36;
bevacizumab IV over 30-90 minutes on days 1*, 15, and 29 OR on days 1 and 22; and irinotecan
IV over 30-90 minutes (at the same dose and schedule that the patient previously received)
beginning on day 1.
ARM B: Patients receive cetuximab as in Arm A and bevacizumab IV over 30-90 minutes on days
1*, 15, and 29.
NOTE: *Bevacizumab is given on day 2 (instead of day 1) of course 1, and is given on day 1
of subsequent courses.
In both arms, courses repeat every 6 weeks in the absence of disease progression or
unacceptable toxicity.
Patients are followed for 3 years.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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