OBELIX Study: A Study of Avastin (Bevacizumab) in Combination With XELOX in Patients With Metastatic Cancer of the Colon or Rectum.

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This single arm study will evaluate the efficacy and safety of a first-line regimen of Avastin and XELOX (oxaliplatin + Xeloda) in patients with metastatic cancer of the colon or rectum. Patients will receive 21-day cycles of treatment, comprising Avastin 7.5mg/kg iv on day 1, oxaliplatin 130mg/m2 iv on day 1, and Xeloda 1000mg/m2 po twice daily on days 1-14, for a maximum of 6 months. Patients with stable disease or complete or partial response may continue on Avastin therapy. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Bevacizumab; Capecitabine; Oxaliplatin

Criteria

Inclusion Criteria:

• adult patients, >=18 years of age;

• locally advanced or metastatic colorectal cancer;

• no previous treatment with chemotherapy for metastatic disease;

• at least one measurable lesion.

Exclusion Criteria:

• radiotherapy to any site within 4 weeks before study;

• untreated brain metastases or primary brain tumors;

• clinically significant cardiovascular disease;

• chronic daily treatment with high dose aspirin (>325 mg/day);

• other co-existing malignancies or malignancies diagnosed within last 5 years.