A Phase III Trial of 6 Versus 12 Treatments of Adjuvant FOLFOX Plus Celecoxib or Placebo for Patients With Resected Stage III Colon Cancer
A Phase III Trial of 6 Versus 12 Treatments of Adjuvant FOLFOX Plus Celecoxib or Placebo for Patients With Resected Stage III Colon Cancer
PURPOSE: This randomized phase III trial is studying giving oxaliplatin, leucovorin calcium, and fluorouracil together to compare how well they work when given together with or without celecoxib in treating patients with stage III colon cancer previously treated with surgery.
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving oxaliplatin, leucovorin calcium, and fluorouracil is more effective with or without celecoxib in treating colon cancer.
OUTLINE: This is a multicenter study. Patients are stratified according to number of positive lymph nodes* (1-3 vs 4 or more) and concurrent regular low-dose of aspirin (yes vs no). Patients are randomized to 1 of 4 treatment arms. Please see the "Arms" section for more information. In all arms, treatment with celecoxib or placebo continues for 3 years in the absence of disease progression or unacceptable toxicity. Blood and tissue samples maybe collected for biomarker analysis and pharmacogenomic studies. The primary and secondary objectives for the research study are described below.
Primary objective:
1. To compare disease-free survival of patients with stage III colon cancer randomized to standard chemotherapy only FOLFOX or standard chemotherapy FOLFOX with 3 years of celecoxib 400 mg daily.
Secondary objectives:
After completion of study therapy, patients are followed up every 6 months for up to 6 years.
Requirements for tumor parameters
NSAID use
Patients are ineligible if they plan on regular use of NSAIDs at any dose more than 2 times per week (on average) or aspirin at more than 325 mg at least three times per week, on average. Low-dose aspirin not exceeding 100 mg/day is permitted. Patients who agree to stop regular NSAIDs or higher dose aspirin are eligible and no was out period is required.
Patient history
No previous or concurrent malignancy, except treated basal cell or squamous cell cancer of skin, treated in situ cervical cancer, treated lobular or ductal carcinoma in situ in one breast, or any other cancer for which the patient has been disease-free for at least 5 years.
No neurosensory or neuromotor toxicity ≥ grade 2 at the time of registration.
No known allergy to platinum compounds.
No prior allergic reaction or hypersensitivity to sulfonamides, celecoxib or NSAIDs.
No history of upper gastrointestinal ulceration, upper gastrointestinal bleeding, or upper gastrointestinal perforation within the past 3 years. Patients with ulceration, bleeding or perforation in the lower bowel are not excluded.
No symptomatic pulmonary fibrosis or interstitial pneumonitis ≥ grade 2.
No cardiac risk factors including:
Pregancy/nursing status
Non-pregnant and not nursing. Men and women of childbearing potential must agree to employ adequate contraception for the duration of chemotherapy and for as many as 8 weeks after the completion of chemotherapy due to the unknown teratogenic effects of FOLFOX on the developing fetus.
Age and performance status
Required initial laboratory values
Burbank, California 91505, United States
Cameron Park, California 95682, United States
Englewood, California 80113, United States
Roseville, California 95661, United States
Sacramento, California 95817, United States
Vacaville, California 95687, United States
Sanford, Delaware 19973, United States
Washington D.C., District of Columbia 20422, United States
Peoria, Illinois 61615, United States
Louisville, Kentucky 40202, United States
Shreveport, Louisiana 71130-3932, United States
Baltimore, Maryland 21237, United States
Milford, Massachusetts 01757, United States
South Weymouth, Massachusetts 02190, United States
Jefferson City, Missouri 65109, United States
Las Vegas, Nevada 89113, United States
Mount Holly, New Jersey 08060, United States
Albuquerque, New Mexico 87108, United States
New Hyde Park, New York 11040, United States
New York, New York 10025, United States
Harrisburg, Pennsylvania 17105, United States
Williamsport, Pennsylvania 17701, United States
Greenville, South Carolina 29605, United States
Spartanburg, South Carolina 29307, United States
San Antonio, Texas 78229-3900, United States
White River Junction, Vermont 05009, United States
Fairfax, Virginia 22031, United States
Yakima, Washington 98902, United States
Eau Claire, Wisconsin 54703, United States
Stevens Point, Wisconsin 54481, United States
Summit, Wisconsin 53066, United States
Saint Catharines, Ontario ON L2S 0A9, Canada
Charlottetown, Prince Edward Island C1A 8T5, Canada