Irinotecan, 5-Fluorouracil and Leucovorin With or Without Iressa in the Treatment of Metastatic Colorectal Cancer
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
1 other identifier
interventional
190
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2004
Shorter than P25 for phase_2
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2004
CompletedFirst Submitted
Initial submission to the registry
October 4, 2005
CompletedFirst Posted
Study publicly available on registry
October 6, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2006
CompletedJanuary 27, 2011
January 1, 2011
1.5 years
October 4, 2005
January 25, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to progression (6 months after Last patient in)
Secondary Outcomes (1)
Objective Response Rate, Duration of Response, Disease control rate, Overall Survival, (6 months after Last patient in)
Interventions
Eligibility Criteria
You may qualify if:
- Histologically confirmed metastatic colorectal cancer
- Presence of measurable metastases
- No previous treatment for metastatic cancer
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (13)
Research Center
Bari, Italy
Research Site
Bergamo, Italy
Research Site
Catania, Italy
Research Site
Cremona, Italy
Research Site
Cuneo, Italy
Research Site
La Spezia, Italy
Research Site
L’Aquila, Italy
Research Site
Milan, Italy
Research Site
Palermo, Italy
Research Site
Pescara, Italy
Research Site
Rozzano, Italy
Research Site
Torino, Italy
Research Site
Venezia, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AstraZeneca Italy Medical Director, MD
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 4, 2005
First Posted
October 6, 2005
Study Start
July 1, 2004
Primary Completion
January 1, 2006
Study Completion
January 1, 2006
Last Updated
January 27, 2011
Record last verified: 2011-01