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

• Status: Completed
• Trial end date: 2007-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is 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 whose disease has worsened after treatment with irinotecan.

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

Details

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

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