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

Phase 3

Completed

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

• Registration Number: NCT00056459
• Lead Sponsor: Novartis

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2003-02
• Study First Submitted: 2003-03-13
• Study First Submitted QC: 2003-03-13
• Study First Posted: 2003-03-14
• Primary Completion: 2007-01
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-06
• Last Update Posted: 2020-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1168

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Progression free survival	Throughout duration of study

Secondary Outcome Measures

Name	Time	Method
Time to progression	Throughout duration of study
Time to treatment failure	Throughout duration of study
Tolerability and safety profile	Throughout duration of study
Best overall response rate	Throughout duration of study

Trial Locations

Locations (144)

Alabama Hematology/Oncology; 🇺🇸 Birmingham, Alabama, United States

Palo Verde Hematology & Oncology; 🇺🇸 Glendale, Arizona, United States

Arizona Cancer Center; 🇺🇸 Tucson, Arizona, United States

Northeast Arkansas Clinic; 🇺🇸 Jonesboro, 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

California Oncology of the Central Valley; 🇺🇸 Fresno, California, United States

Virginia K. Crosson Cancer Center; 🇺🇸 Fullerton, California, United States

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