Overview

A Study of Xeloda (Capecitabine) in Combination With Oxaliplatin in Patients With Metastatic Colorectal Cancer.

Status:
Completed

Trial end date:
2008-04-01

Target enrollment:
0

Participant gender:
All

Summary

This single arm study will investigate possible pharmacokinetic interactions between Xeloda and oxaliplatin, and assess whether the pharmacokinetics of Xeloda and/or oxaliplatin is influenced by the addition of Avastin. All subjects will provide samples for pharmacokinetic analysis during the first 3 cycles of treatment. In cycles 1 and 2 patients will receive a treatment regimen containing Xeloda (1000mg/m2 bid) and oxaliplatin (130mg/m2 iv) and in cycle 3 Avastin (7.5mg/kg iv) will be added to the regimen. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.

Phase:

Phase 1

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Hoffmann-La Roche

Treatments:

Bevacizumab
Capecitabine
Oxaliplatin

Criteria

Inclusion Criteria:

- adult patients, >=18 years of age;

- adenocarcinoma of colon or rectum, with metastatic or locally advanced disease.

Exclusion Criteria:

- previous systemic treatment for advanced or metastatic disease;

- previous treatment with oxaliplatin or Avastin.