Study of Modified FOLFOX6 Plus or Minus Sorafenib in Stage IV Metastatic Colorectal Carcinoma (mCRC) Subjects

Summary

To determine if sorafenib when added to chemotherapy will slow disease progression more than chemotherapy alone in patients previously untreated for metastatic colorectal cancer.

Timeline

Start

2009-03

Primary completion

2011-01

Completion

2012-02

Outcome

Missed primary endpoint

paper CONCLUSION: This study did not detect a PFS benefit with the addition of sorafenib to first-line mFOLFOX6 for mCRC. PMID 23532888 ↗

registry p = 0.2309; Hazard Ratio (HR) 0.884 (95% CI 0.635 to 1.231) NCT00865709 ↗

Publications

• Results Tabernero J, Garcia-Carbonero R, Cassidy J, Sobrero A, Van Cutsem E, Kohne CH, Tejpar S, Gladkov O, Davidenko I, Salazar R, Vladimirova L, Cheporov S, Burdaeva O, Rivera F, Samuel L, Bulavina I, Potter V, Chang YL, Lokker NA, O'Dwyer PJ. Sorafenib in combination with oxaliplatin, leucovorin, and fluorouracil (modified FOLFOX6) as first-line treatment of metastatic colorectal cancer: the RESPECT trial. Clin Cancer Res. 2013 May 1;19(9):2541-50. doi: 10.1158/1078-0432.CCR-13-0107. Epub 2013 Mar 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sorafenib	Small molecule	400 mg	Oral
Background	Levoleucovorin	Unknown	200 mg/m2	Intravenous
Background	Oxaliplatin	Small molecule	85 mg/m2	Intravenous
Background	fluorouracil	Small molecule	400 mg/m2	Intravenous
Background	fluorouracil	Small molecule	2400 mg/m2	Intravenous

Indications