A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Chinese Patients With Metastatic Colorectal Cancer.
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
214 participants in 2 patient groups
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal