A Randomized, Double-blind, Placebo-controlled, Phase III Study of Oxaliplatin/5-fluorouracil/Leucovorin With PTK787/ZK 222584 or Placebo in Patients With Previously Treated Metastatic Adenocarcinoma of the Colon or Rectum

Inclusion Criteria

Inclusion criteria

- Confirmed adenocarcinoma of the colon or rectum in patients with metastatic disease

- One prior chemotherapy regimen with irinotecan and 5FU

- Evidence of progressive disease within 6 months after last dose of irinotecan

- 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 within 3 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 oxaliplatin

- Peripheral neuropathy with functional impairment

- Female patients who are pregnant or breast feeding

- Any severe or uncontrolled medical condition which could prevent participation in
study

- Chronic kidney disease

- Acute or chronic liver disease

- Patients taking Coumadin