Irinotecan, 5-Fluorouracil and Leucovorin With or Without Iressa in the Treatment of Metastatic Colorectal Cancer
Primary Purpose
Metastatic Colorectal Cancer
Status
Withdrawn
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Iressa (Gefitinib)
Irinotecan
5Fluorouracil
Leucovorin
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Colorectal Cancer focused on measuring Metastatic Colorectal Cancer
Eligibility Criteria
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)
Sites / Locations
- Research Center
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
Outcomes
Primary Outcome Measures
Time to progression (6 months after Last patient in)
Secondary Outcome Measures
Objective Response Rate, Duration of Response, Disease control rate, Overall Survival, (6 months after Last patient in)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00233623
Brief Title
Irinotecan, 5-Fluorouracil and Leucovorin With or Without Iressa in the Treatment of Metastatic Colorectal Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Withdrawn
Study Start Date
July 2004 (undefined)
Primary Completion Date
January 2006 (Anticipated)
Study Completion Date
January 2006 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colorectal Cancer
Keywords
Metastatic Colorectal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
190 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Iressa (Gefitinib)
Intervention Type
Drug
Intervention Name(s)
Irinotecan
Intervention Type
Drug
Intervention Name(s)
5Fluorouracil
Intervention Type
Drug
Intervention Name(s)
Leucovorin
Primary Outcome Measure Information:
Title
Time to progression (6 months after Last patient in)
Secondary Outcome Measure Information:
Title
Objective Response Rate, Duration of Response, Disease control rate, Overall Survival, (6 months after Last patient in)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca Italy Medical Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Center
City
Bari
Country
Italy
Facility Name
Research Site
City
Bergamo
Country
Italy
Facility Name
Research Site
City
Catania
Country
Italy
Facility Name
Research Site
City
Cremona
Country
Italy
Facility Name
Research Site
City
Cuneo
Country
Italy
Facility Name
Research Site
City
L'Aquila
Country
Italy
Facility Name
Research Site
City
La Spezia
Country
Italy
Facility Name
Research Site
City
Milano
Country
Italy
Facility Name
Research Site
City
Palermo
Country
Italy
Facility Name
Research Site
City
Pescara
Country
Italy
Facility Name
Research Site
City
Rozzano
Country
Italy
Facility Name
Research Site
City
Torino
Country
Italy
Facility Name
Research Site
City
Venezia
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Irinotecan, 5-Fluorouracil and Leucovorin With or Without Iressa in the Treatment of Metastatic Colorectal Cancer
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