A Study of Avastin (Bevacizumab) in Combination With XELOX in Patients With Metastatic Colorectal Cancer

Roche

Status and phase: Completed; Phase 2

Conditions: Colorectal Cancer

Treatments: Drug: bevacizumab [Avastin]; Drug: oxaliplatin; Drug: capecitabine [Xeloda]

Study type: Interventional

Funder types: Industry

Identifiers

NCT00700570

ML21209

Details and patient eligibility

About

This single arm study will assess the resection rate of liver metastasis, time to disease progression, and safety of neoadjuvant treatment with Avastin in combination with oxaliplatin and capecitabine (XELOX) in patients with metastatic colorectal cancer with unresectable liver metastasis. Patients will receive Avastin 5mg/kg iv on day 1 of every 2 week cycle, oxaliplatin 85mg/m2 iv on day 1 of every 2 week cycle, and capecitabine 1000mg/m2 on days 1-5 and 8-12 of every 2 week cycle. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.

Enrollment: 45 patients

Sex: All

Ages: Under 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients, <=75 years of age;
• chemotherapy-naive for stage IV colorectal cancer with unresectable liver metastasis;
• >=1 measurable lesion;
• ECOG status 0-2.

Exclusion criteria

• prior exposure to Avastin;
• clinical or radiological evidence of CNS metastases;
• uncontrolled hypertension, or clinically significant cardiovascular disease;
• ongoing treatment with aspirin (>325mg/day) or other medications known to predispose to gastrointestinal ulceration.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

1

Experimental group

Treatment:

Drug: oxaliplatin

Drug: capecitabine [Xeloda]

Drug: bevacizumab [Avastin]