Ph II Trial of a Novel Anti-angiogenic Agent in Combination With Chemotherapy for the Second-line Treatment of Metastatic Colorectal Cancer

A Randomized, Double-Blind, Phase II Trial of CT-322 (BMS-844203) Plus Irinotecan, 5-FU and Leucovorin (FOLFIRI) Versus Bevacizumab Plus FOLFIRI as Second-Line Treatment for Metastatic Colorectal Cancer

The purpose of this study is to determine the efficacy of CT-322 comparative to bevacizumab, both in combination with irinotecan, 5-FU and leucovorin in the second-line treatment of subject with metastatic colorectal cancer

Inclusion Criteria:

• ECOG Performance Status (PS) ≤1
• Histologically or cytologically confirmed, unresectable metastatic colorectal cancer
• Measurable disease by RECIST guidelines
• Evidence of disease progression following first-line therapy with a fluoropyrimidine, oxaliplatin, and bevacizumab (≤ 8 weeks since last dose)
• Available paraffin embedded tumor tissue
• Willing to give a whole blood sample for the study of proteins and genetic polymorphisms

Exclusion Criteria:

• Less than 28 days elapsed since major surgery at time of randomization
• Known CNS metastases
• Excessive risk of bleeding (including use of therapeutic anticoagulation other than low dose aspirin) and history of thrombotic or embolic cerebrovascular accident
• Uncontrolled hypertension
• Clinically significant cardiovascular disease
• History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
• Serious non-healing wound, active peptic ulcer, non-healing bone fracture, or bleeding skin metastasis
• Known HIV Positive