Study of Oxaliplatin/5-FU/Leucovorin Plus Vatalanib Versus Oxaliplatin/5-FU/Leucovorin in Patients With Metastatic Colorectal Cancer.

Inclusion criteria:

Patients with metastatic colorectal cancer coming for initial chemotherapy
Documented metastatic colorectal cancer
WHO Performance Status of 0, 1, or 2
Measurable tumors
Adequate hematologic status, liver and kidney function
Life expectancy greater than 12 weeks
Written informed consent obtained

Exclusion criteria:

History or presence of central nervous system disease
Patients with a history of another primary cancer within 5 years
Prior chemotherapy for metastatic colorectal cancer
Prior full field radiotherapy within 4 weeks or limited field radiotherapy within 2 weeks before entry to study
Major surgery within 4 weeks or minor surgery within 2 weeks before entry to study
Investigational drugs within 4 weeks before entry to study
Prior therapy with anti-VEGF agents
Any prior therapy with oxaliplatin or allergy to platinum-containing drugs
Peripheral neuropathy with functional impairment
Female patients who are pregnant or breast feeding
Any severe or uncontrolled medical conditions which could prevent participation in study
Patients who are taking Coumadin

Other protocol-defined inclusion / exclusion criteria may apply