Trial information
A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Chinese Patients With Metastatic Colorectal Cancer.
Status: No longer recruiting
Protocol number: BO20696
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: 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.
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. Target sample size is 210.
Study phase: III
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
Condition: Colorectal Cancer
Intervention type: Drug
Intervention name: bevacizumab [Avastin]
Primary outcome: 1. Progression-free survival. Time frame: 6 months
Key secondary outcomes: 1. Overall response rate, time to response, duration of response, overall survival. Time frame: Event driven
2. AEs, laboratory tests Time frame: Throughout study
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.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: July, 2007
Trial registration date: 03/18/2008
Date last updated: 10/15/2008
Link to trial result
This trial was conducted at the following locations:
China
- Beijing
- Chongqing
- Guangdong
- Guangzhou
- Nanjing
- Qingdao
- Shanghai
- Tianjin
- Wuhan
