Irinotecan, 5-Fluorouracil and Leucovorin With or Without Iressa in the Treatment of Metastatic Colorectal Cancer

Phase 2

Withdrawn

• Conditions: Metastatic Colorectal Cancer

• Registration Number: NCT00233623
• Lead Sponsor: AstraZeneca

Brief Summary

The aim of the study is to determine if Iressa added to chemotherapy with Irinotecan, 5Fluorouracil and Leucovorin can prolong the period of time without any disease worsening (Time to Progression) in patients with metastatic colorectal cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-07
• Study First Submitted: 2005-10-04
• Study First Submitted QC: 2005-10-04
• Study First Posted: 2005-10-06
• Primary Completion: 2006-01
• Study Completion: 2006-01
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-25
• Last Update Posted: 2011-01-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 190

Inclusion Criteria

• Histologically confirmed metastatic colorectal cancer
• Presence of measurable metastases
• No previous treatment for metastatic cancer

Exclusion Criteria

• No presence of Central Nervous System metastases
• No other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
• Any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time to progression (6 months after Last patient in)

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate, Duration of Response, Disease control rate, Overall Survival, (6 months after Last patient in)

Trial Locations

Locations (2)

Research Center; 🇮🇹 Bari, Italy

Research Site; 🇮🇹 Venezia, Italy