A Randomized Phase II Study of Bevacizumab in Combination With Cetuximab Plus Irinotecan, or in Combination With Cetuximab Alone, in Irinotecan-Refractory Colorectal Cancer
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
Patients are followed for 3 years.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Time to tumor progression
Date of randomization to the date of either documentation of disease progression, or death, assessed up to 3 years
Memorial Sloan-Kettering Cancer Center
United States: Food and Drug Administration
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|