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Sponsor: Hoffmann-La Roche
Conditions: Colorectal Cancer
Interventions: bevacizumab [Avastin], irinotecan, leucovorin, fluorouracil
Countries: China
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.
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
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.
- Beijing, China
- Beijing, China
- Beijing, China
- Chongqing, China
- Guangdong, China
- Guangzhou, China
- Nanjing, China
- Qingdao, China
- Shanghai, China
- Shanghai, China
- Tianjin, China
- Wuhan, China