drugset / Trial / NCT00457691

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

NCT00457691

Phase 3 Completed 768 enrolled Pfizer
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2007-06
Primary completion
2010-03
Completion
2010-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Sunitinib Small molecule 37.5 mg
Comparator Irinotecan Small molecule 180 mg/m2 Intravenous
Comparator Leucovorin Small molecule 200 mg/m2 Intravenous
Comparator fluorouracil Small molecule 2400 mg/m2 Other

Indications