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.
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 214
- Primary Endpoint
- Progression-free survival.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
2
Intervention: leucovorin (Drug)
1
Intervention: bevacizumab [Avastin] (Drug)
1
Intervention: irinotecan (Drug)
1
Intervention: leucovorin (Drug)
1
Intervention: fluorouracil (Drug)
2
Intervention: irinotecan (Drug)
2
Intervention: fluorouracil (Drug)
Outcomes
Primary Outcomes
Progression-free survival.
Time Frame: 6 months
Secondary Outcomes
- AEs, laboratory tests(Throughout study)
- Overall response rate, time to response, duration of response, overall survival.(Event driven)