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

Phase 3

Completed

• Conditions: Colorectal Neoplasms; Rectal Neoplasms; Colonic Neoplasms
• Interventions: Drug: Vatalanib

• Registration Number: NCT00056446
• Lead Sponsor: Novartis Pharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-01
• Study First Submitted: 2003-03-13
• Study First Submitted QC: 2003-03-13
• Study First Posted: 2003-03-14
• Primary Completion: 2007-01
• Study Completion: 2007-01
• Status Verified: 2016-01
• Last Update Submitted: 2017-03-02
• Last Update Posted: 2017-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 855

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Vatalanib	Oxaliplatin/5-FU/LV and PTK787/ZK 222584
2	Vatalanib	Oxaliplatin/5-FU/LV and placebo

Primary Outcome Measures

Name	Time	Method
Overall survival	throughout duration of study

Secondary Outcome Measures

Name	Time	Method
Tolerability and safety profile	throughout duration of study
Progression free survival	throughout duration of study
Time to progression	throughout duration of study
Tumor response rate	throughout duration of study
Time to treatment failure	throughout duration of study

Trial Locations

Locations (143)

Comprehensive Cancer Institute; 🇺🇸 Huntsville, Alabama, United States

Alaska Oncology and Hematology; 🇺🇸 Anchorage, Alaska, United States

Arizona Clinical Research Center; 🇺🇸 Tucson, Arizona, United States

Northeast Arkansas Clinic; 🇺🇸 Jonesboro, Arkansas, United States

Arkansas Cancer Research Center; 🇺🇸 Little Rock, Arkansas, United States

Little Rock Hematology & Oncology; 🇺🇸 Little Rock, Arkansas, United States

Highlands Oncology Group; 🇺🇸 Springdale, Arkansas, United States

Comprehensive Blood and Cancer Center; 🇺🇸 Bakersfield, California, United States

Providence St. Joseph Medical Center; 🇺🇸 Burbank, California, United States

Compassionate Cancer Care Medical Group, Inc.; 🇺🇸 Fountain Valley, California, United States

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