OPAL Study: A Study of Avastin (Bevacizumab) in Combination With FOLFOXIRI in Patients With Previously Untreated Metastatic Colorectal Cancer

Roche

Status and phase

Completed

Phase 2

Conditions

Colorectal Cancer

Treatments

Drug: irinotecan

Drug: 5-FU

Drug: oxaliplatin

Drug: leucovorin

Drug: bevacizumab [Avastin]

Study type

Interventional

Funder types

Industry

Identifiers

NCT00940303

2008-001180-11

ML20514

Details and patient eligibility

About

This single arm study will assess progression-free survival, feasibility of use and safety of Avastin in combination with 5-FU/FA, oxaliplatin and irinotecan (FOLFOXIRI) as first line treatment in patients with metastatic colorectal cancer. Patients will receive up to 12 bi-weekly cycles of Avastin (5mg/kg iv) in combination with this standard neoadjuvant chemotherapy regimen followed by up to 40 bi-weekly cycles with Avastin plus 5-FU/FA. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.

Enrollment

97 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

adult patients, 18-70 years of age;
metastatic colorectal cancer scheduled for standard first line chemotherapy;
at least 1 measurable lesion;
ECOG performance score of 0 or 1.

Exclusion criteria

prior chemotherapy for metastatic colorectal cancer;
prior (neo)adjuvant chemotherapy/radiotherapy of a non-metastatic malignancy completed within 6 months prior to study entry;
concomitant malignancies other CRC;
history or evidence of CNS disease unrelated to cancer.