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

Completed · Phase 3

Conditions studied: Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms

In brief

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.

Key facts

Study ID

NCT00056446

Run by

Novartis Pharmaceuticals

People needed

855

Starts

2003-01-01

Expected to finish

2007-01-01

Last updated by the study team

2017-03-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• California Oncology of the Central Valley — Fresno, California, United States
• Virginia K. Crosson Cancer Center — Fullerton, California, United States
• Glendale Adventist Medical Center — Glendale, California, United States
• Scripps Green Hospital — La Jolla, California, United States
• Wilshire Oncology Medical Group — La Verne, California, United States
• Pacific Shores Medical Group — Long Beach, California, United States
• USC Norris Cancer Center — Los Angeles, California, United States
• Synergy Hematology-Oncology Medical Associates — Los Angeles, California, United States
• Novartis Investigative Site — Los Angeles, California, United States
• UCLA School of Medicine — Los Angeles, California, United States
• Eddie Hong-Lung Hu, M.D. — Monterey Park, California, United States
• North Valley Hematology/Oncology Medical Group — Northridge, California, United States
• Medical Oncology Care Associates — Orange, California, United States
• Ventura County Hematology-Oncology Specialists — Oxnard, California, United States
• Sierra View District Hospital — Porterville, California, United States
• Comprehensive Cancer Institute — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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