A Study of Avastin (Bevacizumab) and Oxaliplatin Plus Xeloda (Capecitabine) in Patients With Advanced Colorectal Cancer.

Roche

Status and phase: Completed; Phase 2

Conditions: Colorectal Cancer

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01159171

ML18523

Details and patient eligibility

About

This study will assess the efficacy and safety of treatment with the combination Avastin (bevacizumab) 5mg/kg iv every 2 weeks, Xeloda (capecitabine) 1000 mg po b.i.d. on Days 1-14 of every 28-day cycle and oxaliplatin 40mg/m2 iv weekly in patients with inoperable locally advanced or metastatic colorectal cancer. The anticipated time on study treatment is until disease progression.

Enrollment: 50 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
• Measurable and/or evaluable lesions

Exclusion criteria

• Radiotherapy within 4 weeks before study
• Untreated brain metastases or primary brain tumors
• Chronic, daily treatment with high-dose aspirin (>325mg/day)
• Co-existing malignancies, or malignancies diagnosed within the last 5 years, with the exception of basal and squamous cell cancer, or cervical cancer in situ

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

1

Experimental group

Treatment:

Drug: oxaliplatin

Drug: bevacizumab [Avastin]

Drug: capecitabine [Xeloda]