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

• Pharmacokinetic parameters of capecitabine and its metabolites, and free platinum [ Time Frame: Cycles 1, 2 and 3 of treatment ] [ Designated as safety issue: No ]
• AEs, laboratory parameters [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

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.

• Drug: capecitabine [Xeloda]
  1000mg/m2 po bid (cycles 1, 2 and 3)
• Drug: Oxaliplatin
  130mg/m2 iv (cycles 1, 2 and 3)
• Drug: Avastin
  7.5mg/kg iv (cycle 3 only)

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.