Trial Information
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
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)
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Time to progression (6 months after Last patient in)
Principal Investigator
AstraZeneca Italy Medical Director, MD
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca
Authority:
Italy: Ministry of Health
Study ID:
1839IL/0138
NCT ID:
NCT00233623
Start Date:
July 2004
Completion Date:
January 2006
Related Keywords:
- Metastatic Colorectal Cancer
- Metastatic Colorectal Cancer
- Colorectal Neoplasms