Phase I Irinotecan, 5-Fluorouracil and Leucovorin Combination

Phase 1 Completed 24 enrolled Genzyme, a Sanofi Company

RandomizedSingle-groupOpen-labelTreatment

Summary

A Phase I open label study to asses the safety and tolerability of ZD6474 in combination with Irinotecan, 5-Fluorouracil and Leucovorin (FOLFIRI) as first or second line therapy in patients with metastatic colorectal adenocarcinoma.

Timeline

Start: 2005-08
Primary completion: 2006-05
Completion: 2008-06

Publications

Background Saunders MP, Wilson R, Peeters M, Smith R, Godwood A, Oliver S, Van Cutsem E. Vandetanib with FOLFIRI in patients with advanced colorectal adenocarcinoma: results from an open-label, multicentre Phase I study. Cancer Chemother Pharmacol. 2009 Sep;64(4):665-72. doi: 10.1007/s00280-008-0914-4. Epub 2009 Jan 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Vandetanib	Small molecule	100 mg	Oral
Subject	Vandetanib	Small molecule	300 mg	Oral
Background	Irinotecan	Small molecule	—	Intravenous
Background	Leucovorin	Small molecule	—	Intravenous
Background	fluorouracil	Small molecule	—	Intravenous

Phase I Irinotecan, 5-Fluorouracil and Leucovorin Combination

Summary

Timeline

Publications

Drugs

Indications