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

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

Outcome

Missed primary endpoint

paper The PFS hazard ratio was 1.095 (95% CI, 0.892 to 1.344; one-sided stratified log-rank P = .807), indicating a lack of superiority for sunitinib plus FOLFIRI. PMID 23358972 ↗

Publications

Carrato A, Swieboda-Sadlej A, Staszewska-Skurczynska M, Lim R, Roman L, Shparyk Y, Bondarenko I, Jonker DJ, Sun Y, De la Cruz JA, Williams JA, Korytowsky B, Christensen JG, Lin X, Tursi JM, Lechuga MJ, Van Cutsem E. Fluorouracil, leucovorin, and irinotecan plus either sunitinib or placebo in metastatic colorectal cancer: a randomized, phase III trial. J Clin Oncol. 2013 Apr 1;31(10):1341-7. doi: 10.1200/JCO.2012.45.1930. Epub 2013 Jan 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
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