A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Previously Untreated Metastatic Colorectal Cancer.

Roche

Status and phase

Withdrawn

Phase 2

Conditions

Colorectal Cancer

Treatments

Drug: Cetuximab

Drug: Irinotecan

Drug: 5 FU

Drug: Leucovorin

Drug: bevacizumab [Avastin]

Study type

Interventional

Funder types

Industry

Identifiers

NCT00577109

ML20452

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.