A Study of Avastin (Bevacizumab) in Combination With Xelox and Tarceva in Patients With Metastatic Colorectal Cancer.

Roche

Status and phase: Completed; Phase 2

Conditions: Colorectal Cancer

Treatments: Drug: capecitabine [Xeloda]; Drug: eloxatin; Drug: bevacizumab [Avastin]; Drug: erlotinib [Tarceva]

Study type: Interventional

Funder types: Industry

Identifiers

NCT01135498

ML19875

Details and patient eligibility

About

This study will evaluate the efficacy and safety of a first-line regimen of Avastin and Xelox (Xeloda + Eloxatin) followed by Avastin and Tarceva, in patients with metastatic colorectal cancer. Patients will receive 6 x 21 day cycles of treatment with Avastin (7.5mg/kg iv on day 1), Xeloda (1000mg/m2 po twice daily on days 1 to 14) and Eloxatin (130mg/m2 iv on day 1). Patients free of disease progression will then continue with Avastin (7.5mg/kg iv once every 3 weeks) and Tarceva (150mg po daily). The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients, >=18 years of age;
• adenocarcinoma of colon or rectum, with metastatic disease;
• >=1 measurable lesion.

Exclusion criteria

• previous treatment with Avastin or Tarceva;
• previous systemic treatment for advanced or metastatic disease;
• adjuvant treatment for non-metastatic disease in past 6 months.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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90 participants in 1 patient group

1

Experimental group

Treatment:

Drug: bevacizumab [Avastin]

Drug: erlotinib [Tarceva]

Drug: capecitabine [Xeloda]

Drug: eloxatin