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

Completed · Phase 3

Conditions studied: Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms

In brief

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

Key facts

Study ID

NCT00056459

Run by

Novartis

People needed

1168

Starts

2003-02-01

Last updated by the study team

2020-02-10

Who can join

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

You may qualify if…

• 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

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 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

Where it is running

• 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
• Ronald Yanagiharaa, M.D. — Gilroy, California, United States
• Glendale Adventist Medical Center Cancer Center — Glendale, California, United States
• Pacific Shores Medical Group — Long Beach, California, United States
• Cancer Institute Medical Group — Los Angeles, California, United States
• USC/Norris Comprehensive Cancer Care Center — Los Angeles, California, United States
• Synergy Hematology-Oncology Medical Associates — 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
• Ventura County Hematology-Oncology Specialists — Oxnard, California, United States
• Wilshire Oncology Medical Group — Pomona, California, United States
• Sierra View District Hospital — Porterville, California, United States
• The Lucy Curci Cancer Center — Rancho Mirage, California, United States
• Cancer Care Associates Medical Group, Inc. — Redondo Beach, California, United States
• Pacific Hematology Oncology Associates — San Francisco, California, United States
• Alabama Hematology/Oncology — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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