Study of Enzastaurin With 5-Fluorouracil/Leucovorin (5-FU/LV) Plus Bevacizumab as Maintenance Regimen Following First Line Therapy for Metastatic Colon Cancer

Summary

This study will evaluate the addition of enzastaurin to 5-FU (5-fluorouracil)/LV (leucovorin) plus bevacizumab in the maintenance of best response obtained with 6 cycles of first-line therapy consisting of 5-FU/LV + oxaliplatin (FOLFOX) or 5-FU/LV + irinotecan (FOLFIRI), plus bevacizumab in patients with Metastatic Colorectal Cancer.

Timeline

Start

2008-02

Primary completion

2010-01

Completion

2011-11

Outcome

Missed primary endpoint

registry analysis (unspecified test); Enzastaurin + 5-FU/LV + Bev vs Placebo + 5FU/LV + Bev; p = 0.8956; Log Rank; note: One sided NCT00612586 ↗

paper does not improve PFS during maintenance therapy in patients with MCRC compared with bevacizumab-based therapy alone. PMID 22213153 ↗

Publications

• Wolff RA, Fuchs M, Di Bartolomeo M, Hossain AM, Stoffregen C, Nicol S, Heinemann V. A double-blind, randomized, placebo-controlled, phase 2 study of maintenance enzastaurin with 5-fluorouracil/leucovorin plus bevacizumab after first-line therapy for metastatic colorectal cancer. Cancer. 2012 Sep 1;118(17):4132-8. doi: 10.1002/cncr.26692. Epub 2011 Dec 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	enzastaurin	Small molecule	250 mg	Oral
Background	Bevacizumab	Monoclonal antibody	5 mg/kg	Intravenous
Background	Leucovorin	Small molecule	400 mg/m2	Intravenous
Background	fluorouracil	Small molecule	400 mg/m2	Intravenous
Background	fluorouracil	Small molecule	2400 mg/m2	Intravenous

Indications