A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Previously Untreated Metastatic Colorectal Cancer.
Phase 2
Withdrawn
- Conditions
- Colorectal Cancer
- Interventions
- Registration Number
- NCT00577109
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This single arm study will assess the efficacy and safety of a combination of modified FOLFIRI (irinotecan, 5-FU and leucovirin), Avastin and cetuximab in patients with previously untreated metastatic colorectal cancer. Patients will receive modified FOLFIRI (irinotecan 180mg/m2 iv, leucovirin 200mg/m2 iv, and 5-FU 400mg/m2 iv) on day 1 of each 2 week cycle, in combination with Avastin (5mg/kg iv on day 1 of each cycle) and cetuximab (loading dose of 400mg/m2 followed by 250mg/m2 on day 3 of each cycle). The anticipated time on study treatment is until disease progression or unacceptable toxicity, and the target sample size is \<100 individuals.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- adult patients, >=18 years of age;
- colorectal cancer;
- advanced or recurrent disease;
- >=1 measurable lesion;
- >=6 months since prior adjuvant therapy, and >=4 weeks since prior radiotherapy.
Exclusion Criteria
- previous treatment for colorectal cancer;
- significant history of cardiac disease in past 6 months;
- other invasive malignancy within past 5 years, except for nonmelanoma skin cancer, and successfully treated cervical or prostate cancer.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 bevacizumab [Avastin] - 1 5 FU - 1 Irinotecan - 1 Leucovorin - 1 Cetuximab -
- Primary Outcome Measures
Name Time Method Progression-free survival 12 months
- Secondary Outcome Measures
Name Time Method Objective response rate, rate of resection of hepatic metastases, overall survival. Event driven AEs, laboratory parameters. Throughout study