Study Of FOLFIRI Chemotherapy With Or Without Sunitinib In Patients With Metastatic Colorectal Cancer

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to evaluate the safety and efficacy of FOLFIRI (Irinotecan, Leucovorin and 5 Fluorouracil) chemotherapy when combined with sunitinib or FOLFIRI chemotherapy without adding sunitinib as the first line treatment of patients with metastatic colorectal cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Camptothecin; Fluorouracil; Irinotecan; Leucovorin; Levoleucovorin; Sunitinib

Criteria

Inclusion Criteria:

• Confirmed (histologically or cytologically) colorectal adenocarcinoma with metastatic disease.

• Not received previous therapy for metastatic colorectal disease but for whom FOLFIRI treatment is clinically indicated.

• Adequate organ function defined by blood test.

Exclusion Criteria:

• History of another primary cancer in the last 3 years.

• Previous full field radiotherapy within the last 4 weeks or limited field radiotherapy within 2 weeks of enrolling into the study. Or previous radiation treatment of more that 30% of the bone marrow.

• History of presence of brain metastasis, spinal cord compression carcinomatous meningitis or leptomeningeal disease.