A Randomized, Double-blind, Placebo-controlled, Phase Lll Study in Patients With Metastatic Adenocarcinoma of the Colon or Rectum Who Are Receiving First-line Chemotherapy With Oxaliplatin/5-fluorouracil/Leucovorin With PTK787/ZK 222584 or Placebo

Inclusion Criteria

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