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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

To compare treatment with oxaliplatin/5-FU/leucovorin plus vatalanib versus oxaliplatin/5-FU/leucovorin plus placebo in patients with colorectal cancer that has spread to other organs and are seeking first chemotherapy treatment

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis
• Collaborator: Bayer
• Treatments: Oxaliplatin; Vatalanib

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