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

Roche

Status and phase: Completed; Phase 1

Conditions: Colorectal Cancer

Treatments: Drug: Avastin; Drug: Oxaliplatin; Drug: capecitabine [Xeloda]

Study type: Interventional

Funder types: Industry

Identifiers

NCT00353262

NP18587

Details and patient eligibility

About

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.

Enrollment: 36 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 or locally advanced disease.

Exclusion criteria

• previous systemic treatment for advanced or metastatic disease;
• previous treatment with oxaliplatin or Avastin.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

1

Experimental group

Treatment:

Drug: Oxaliplatin

Drug: Avastin

Drug: capecitabine [Xeloda]