Irinotecan, 5-Fluorouracil and Leucovorin with or without Iressa in the treatment of metastatic colorectal cancer

Study identifier:1839IL/0138

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Terminated/Withdrawn

Official Title

A Randomised, Non-Comparative, Multicentre, Phase II, Parallel-Group Trial Of ZD1839 (Iressa™) In Combination With 5 Fluorouracil, Leucovorin And Cpt-11 (Irinotecan) In Patients With Metastatic Colorectal Cancer

Medical condition

Metastatic Colorectal Cancer

Phase

Phase 2

Healthy volunteers

No

Study drug

Iressa (Gefitinib), Irinotecan, 5Fluorouracil, Leucovorin

Sex

All

Actual Enrollment

190

Study type

Interventional

Age

18 Years +

Date

Study Start Date: 01 Jul 2004
Estimated Primary Completion Date: 01 Jan 2006
Estimated Study Completion Date: 01 Jan 2006

Study design

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Nov 2013 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria