Oxaliplatin (NSC 266046) in Combination With 5-Fluorouracil and Leucovorin (FOLFOX4) for Patients Who Have Not Received Prior Chemotherapy for Advanced Colorectal Cancer
- Provide oxaliplatin in combination with fluorouracil and leucovorin calcium using the
FOLFOX4 regimen for front-line treatment in patients with no prior chemotherapy for
advanced colorectal cancer who are not eligible for entry into ongoing clinical trials
of higher priority. (The regimen in this Treatment Referral Center protocol is one that
was found to be superior in a recent national intergroup study.)
- Further determine the safety of this regimen in these patients.
- Further determine the anti-tumor activity of this regimen, defined as the rate of
time-to-treatment failure, time to progression, and survival, in these patients.
- Capture data on subsequent salvage therapy administered to patients treated with this
OUTLINE: This is an open-label, multicenter study.
Patients receive oxaliplatin IV over 2 hours on day 1, leucovorin calcium IV over 2 hours on
days 1 and 2, and fluorouracil IV over 22 hours on days 1 and 2. Courses repeat every 14
days in the absence of disease progression or unacceptable toxicity. Patients with clinical
evidence of benefit from this treatment, defined as stable disease, partial response, or
complete response as well as no increase in size of any measurable or evaluable lesion and
no new sites of disease, may be eligible for additional courses.
Patients are followed until death.
PROJECTED ACCRUAL: A maximum of 300 patients per month will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
S. Percy Ivy, MD
NCI - Investigational Drug Branch
United States: Federal Government
|Mayo Clinic Scottsdale||Scottsdale, Arizona 85259|
|Mayo Clinic Cancer Center||Rochester, Minnesota 55905|
|Lineberger Comprehensive Cancer Center, UNC||Chapel Hill, North Carolina 27599-7295|
|Ireland Cancer Center||Cleveland, Ohio 44106-5065|
|Fox Chase Cancer Center||Philadelphia, Pennsylvania 19111|
|University of California San Diego Cancer Center||La Jolla, California 92093-0658|
|Yale Comprehensive Cancer Center||New Haven, Connecticut 06520-8028|
|NYU School of Medicine's Kaplan Comprehensive Cancer Center||New York, New York 10016|
|Huntsman Cancer Institute||Salt Lake City, Utah 84112|
|Virginia Mason Medical Center||Seattle, Washington 98111|
|Cancer Institute of New Jersey||New Brunswick, New Jersey 08901|
|Louisiana State University School of Medicine||New Orleans, Louisiana 70112-2822|
|Mayo Clinic||Jacksonville, Florida 32224|
|Cancer Center of Kansas - Wichita||Wichita, Kansas 67214|
|Southern Nevada Cancer Research Foundation||Las Vegas, Nevada 89106|
|Atlanta Cancer Care||Atlanta, Georgia 30342|
|Anchorage Oncology Centre||Anchorage, Alaska 99508|
|Cancer Therapy Evaluation Program||Bethesda, Maryland 20852|
|St. Vincent Hospital and Health Center||Billings, Montana 59107-5200|