An Open Label Study to Assess the Effect of FOLFIRI Plus Avastin and Cetuximab on Progression-free Survival in Patients With Previously Untreated Metastatic Colorectal Cancer.
Overview
- Phase
- Phase 2
- Intervention
- bevacizumab [Avastin]
- Conditions
- Colorectal Cancer
- Sponsor
- Hoffmann-La Roche
- Primary Endpoint
- Progression-free survival
- Status
- Withdrawn
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
1
Intervention: bevacizumab [Avastin]
1
Intervention: Irinotecan
1
Intervention: Leucovorin
1
Intervention: 5 FU
1
Intervention: Cetuximab
Outcomes
Primary Outcomes
Progression-free survival
Time Frame: 12 months
Secondary Outcomes
- Objective response rate, rate of resection of hepatic metastases, overall survival.(Event driven)
- AEs, laboratory parameters.(Throughout study)