A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Chinese Patients With Metastatic Colorectal Cancer.
Phase 3
Completed
- Conditions
- Colorectal Cancer
- Interventions
- Registration Number
- NCT00642577
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This 2 arm study will assess the efficacy and safety of Avastin in combination with irinotecan + 5-fluorouracil/folinic acid, versus irinotecan + fluorouracil/folinic acid alone, as first line treatment in Chinese patients with metastatic colorectal cancer. Patients will be randomized 2:1 to receive 6-weekly cycles of Avastin (5mg/kg iv every 2 weeks) + irinotecan 125mg/m2 iv / leucovorin 20mg/m2 iv / fluorouracil 500mg/m2 iv weekly for 4 weeks, or 6-weekly cycles of irinotecan 125mg/m2 iv / leucovorin 20mg/m2 iv / fluorouracil 500mg/m2 iv weekly for 4 weeks. The anticipated time on study treatment is until disease progression, and the sample size is 100-500 individuals.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 214
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 bevacizumab [Avastin] - 1 leucovorin - 1 fluorouracil - 1 irinotecan - 2 irinotecan - 2 fluorouracil - 2 leucovorin -
- Primary Outcome Measures
Name Time Method Progression-free survival. 6 months
- Secondary Outcome Measures
Name Time Method AEs, laboratory tests Throughout study Overall response rate, time to response, duration of response, overall survival. Event driven