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E7208: A Randomized Phase II Study of Irinotecan and Cetuximab with or without the Anti-Angiogenic Antibody, Ramucirumab (IMC-1121B), in Advanced, K-ras Wild-type Colorectal Cancer Following Progression on Bevacizumab-Containing Chemotherapy

Conditions

Colon

Trial Phase

Phase II

Trial Purpose and Description

Trial Purpose

- To evaluate the Progression Free Survival (PFS) for the addition of the anti-angiogenic antibody, Ramucirumab, in combination with irinotecan and cetuximab as second line therapy for patients with K-ras wild-type colorectal cancer, as compared to the patients without the antibody. - To evaluate the Response Rate for irinotecan, cetuximab and Ramucirumab in this patient population. - To evaluate the Grade 3-4 toxicity rates for the combination in this patient population. - To evaluate Overall Survival for irinotecan, cetuximab, and ramucirumab in this patient population.


Participation Guidelines

Age:
Gender:

Eligibility Criteria

Sponsor:
Eastern Cooperative Oncology Group
Dates:
01/15/2011
Last Updated:
Study HIC#:
1010007561