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

• Status: Completed
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Bevacizumab; Calcium; Calcium, Dietary; Camptothecin; Fluorouracil; Irinotecan; Leucovorin; Levoleucovorin; Pharmaceutical Solutions

Criteria

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