A Study of Avastin (Bevacizumab) in Combination With XELOX or FOLFOX-4 in Patients With Metastatic Colorectal Cancer.

Roche

Status and phase: Completed; Phase 3

Conditions: Colorectal Cancer

Treatments: Drug: FOLFOX-4; Drug: XELOX; Drug: bevacizumab [Avastin]

Study type: Interventional

Funder types: Industry

Identifiers

NCT00349336

NO20254

Details and patient eligibility

About

This 2 arm study will compare the pharmacokinetics and safety of Avastin at steady state under 2 different dosing regimens, in combination with XELOX (oxaliplatin + Xeloda) or FOLFOX-4 (oxaliplatin, leucovorin and 5-fluorouracil). Patients randomized to the XELOX arm will receive Avastin (7.5mg/kg iv) on Day 1 of each 3 week cycle; patients randomized to the FOLFOX-4 arm will receive Avastin (5mg/kg iv) on Day 1 of each 2 week cycle. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.

Enrollment: 64 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• patients who have previously received systemic treatment for advanced or metastatic disease;
• patients who have received adjuvant treatment for non-metastatic disease in past 3 months;
• previous therapy with oxaliplatin or Avastin.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: XELOX

Drug: bevacizumab [Avastin]

Drug: bevacizumab [Avastin]

2

Experimental group

Treatment:

Drug: bevacizumab [Avastin]

Drug: bevacizumab [Avastin]

Drug: FOLFOX-4