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

Completed · Phase 2 · Has a placebo group

Conditions studied: Colorectal Cancer (CRC)

In brief

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

Key facts

Study ID

NCT00851045

Run by

Bristol-Myers Squibb

People needed

17

Starts

2009-10-01

Expected to finish

2011-10-01

Last updated by the study team

2015-10-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Acrc/Arizona Clinical Research Center, Inc. — Tucson, Arizona, United States
• Compassionate Cancer Care Medical Group Inc — Fountain Valley, California, United States
• Compassionate Cancer Care Medical Group, Inc — Riverside, California, United States
• Sharp Memorial Hospital — San Diego, California, United States
• Florida Cancer Specialists — Fort Myers, Florida, United States
• Midwest Center For Hematology/Oncology — Joliet, Illinois, United States
• Cancer Center Of Kansas — Wichita, Kansas, United States
• Gurtler, Jayne — Metairie, Louisiana, United States
• Guthrie Clinic, Ltd — Sayre, Pennsylvania, United States
• Pharma Resource — East Providence, Rhode Island, United States
• Sarah Cannon Research Institute — Nashville, Tennessee, United States
• University Of Texas M.D. Anderson Cancer Center — Houston, Texas, United States
• Local Institution — Bahía Blanca, Buenos Aires, Argentina
• Local Institution — Capital Federal, Buenos Aires, Argentina
• Local Institution — Terni, Italy

Full record on ClinicalTrials.gov

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