A Randomized, Open Label Study to Compare the Effect of First-line Treatment With Avastin in Combination With Irinotecan + 5-fluorouracil/Folinic Acid, and Irinotecan + 5-fluorouracil/Folinic Acid Alone, on Progression-free Survival in Chinese Patients With Metastatic Colorectal Cancer.
Phase 3
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer
Both
Colorectal Cancer
Trial Information
A Randomized, Open Label Study to Compare the Effect of First-line Treatment With Avastin in Combination With Irinotecan + 5-fluorouracil/Folinic Acid, and Irinotecan + 5-fluorouracil/Folinic Acid Alone, on Progression-free Survival in Chinese Patients With Metastatic Colorectal Cancer.
Inclusion Criteria:
- adult patients, >=18 years of age;
- histologically confirmed adenocarcinoma of the colon or rectum, with metastatic
disease;
- >=1 measurable lesion;
- ECOG performance status of <=1.
Exclusion Criteria:
- prior systemic therapy for advanced or metastatic disease;
- adjuvant or neo-adjuvant treatment for non-metastatic disease in past 6 months;
- other malignancy within past 5 years, except cured basal cell cancer of skin or cured
cancer in situ of cervix;
- clinically significant cardiovascular disease in past 6 months.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression-free survival.
Outcome Time Frame:
6 months
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
China: Ministry of Health
Study ID:
BO20696
NCT ID:
NCT00642577
Start Date:
July 2007
Completion Date:
December 2010
Related Keywords:
- Colorectal Cancer
- Colorectal Neoplasms
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