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

Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase III

Treatment

Completed

18 and over

Pharmaceutical / Industry

CPTK787 0135/306241
CONFIRM 1, NCT00056459

Trial Description

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

Eligibility 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Novartis Pharmaceuticals Corporation

Bayer Corporation

Novartis / Schering AG, Germany

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00056459
Information obtained from ClinicalTrials.gov on October 15, 2008

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.