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

Roche

Status and phase: Completed; Phase 4

Conditions: Colorectal Cancer

Treatments: Drug: Oxaliplatin; Drug: Xeloda; Drug: bevacizumab [Avastin]

Study type: Interventional

Funder types: Industry

Identifiers

NCT00577031

ML21380

Details and patient eligibility

About

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.

Enrollment: 205 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

205 participants in 1 patient group

1

Experimental group

Treatment:

Drug: Xeloda

Drug: Oxaliplatin

Drug: bevacizumab [Avastin]