Oxaliplatin, Leucovorin Calcium, and Fluorouracil With or Without Celecoxib in Treating Patients With Stage III Colon Cancer Previously Treated With Surgery

Status: Recruiting
Phase: Phase 3
Diagnosis: Colorectal Cancer, Gastrointestinal Malignancies
NCT ID: NCT01150045 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 10-259


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.


Conducting Institutions:
Dana-Farber Cancer Institute, Massachusetts General Hospital, Brigham and Women's Hospital, Beth-Israel Deaconess Medical Center, DF/BWCC at South Shore Hospital, Massachusetts General Hospital/ North Shore Cancer Center, Dana Farber Cancer Institute at Milford, Dana Farber Cancer Institute at Faulkner Hospital, Dana Farber Cancer Institute at Londonderry

Overall PI:
David P. Ryan, MD, Massachusetts General Hospital

Site-responsible Investigators:
Andrea Bullock, M.D., Beth Israel Deaconess Medical Center
Jeffrey Meyerhardt, MD, Dana-Farber Cancer Institute
Peter Enzinger, MD, Dana-Farber Cancer Institute
Rolf Freter, MD, Ph.D., Dana Farber Cancer Institute at South Shore
Michael Constantine, M.D., Dana Farber Cancer Institute at Milford Hosptial
Lauren Dias, M.D., Dana Farber Cancer Institute at Londonderry Hospital
Frederick Briccetti, M.D., Dana Farber Cancer Institute at Londonderry Hospital

Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100
Beth-Israel Deaconess Medical Center: Cancer Trials Call Center, 617-667-3060
Dana-Farber Cancer Institute: Gastrointestinal Research Line, 617-632-5960

Eligibility Criteria

DISEASE CHARACTERISTICS: - Histologically confirmed adenocarcinoma of the colon - Stage III disease - Gross inferior (caudal) margin of the primary tumor must be ≥ 12 cm from the anal verge - No rectal cancer - Synchronous colon cancers allowed - No synchronous colon and rectal primary tumors - Completely resected tumor - Patients with adherent to adjacent structures, en bloc R_o resected tumor, must have it documented in the operative report - At least 1 pathologically confirmed positive lymph node - No evidence of residual involved lymph node disease or metastatic disease PATIENT CHARACTERISTICS: - ECOG performance status 0-2 - Granulocyte count ≥ 1,500/μL - Platelet count ≥ 100,000/μL - Creatinine ≤ 1.5 times upper limit of normal (ULN) - Bilirubin ≤ 1.5 times ULN - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 8 weeks after completion of chemotherapy - No prior or concurrent malignancy except treated basal cell or squamous cell cancer of the skin, treated in situ cervical cancer, treated lobular or ductal carcinoma in situ in 1 breast, or any other cancer for which the patient has been disease-free for ≥ 5 years - No neurosensory or neuromotor toxicity ≥ grade 2 - No known allergy to platinum compounds - No prior allergic reaction or hypersensitivity to sulfonamides, celecoxib, or NSAIDs - No history of upper gastrointestinal ulceration, bleeding, or perforation within the past 3 years - No symptomatic pulmonary fibrosis or interstitial pneumonitis ≥ grade 2 - No cardiac risk factors including, but not limited to, any of the following: - Uncontrolled high BP (systolic BP > 150 mm Hg) - Unstable angina - History of documented myocardial infarction or cerebrovascular accident - NYHA class III-IV heart failure - : PRIOR CONCURRENT THERAPY: - See Disease Characteristics - No concurrent NSAIDs or aspirin at > 325 mg ≥ 3 times per week on average - Low-dose aspirin not exceeding 100 mg/day allowed
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