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COMPLETED

NCT01150045

PHASE3

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

Sponsor: Alliance for Clinical Trials in Oncology

View on ClinicalTrials.gov

Summary

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.

Official title: A Phase III Trial of 6 Versus 12 Treatments of Adjuvant FOLFOX Plus Celecoxib or Placebo for Patients With Resected Stage III Colon Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

2527

Start Date

2010-06

Completion Date

2022-08-11

Last Updated

2026-05-19

Healthy Volunteers

Conditions

Colorectal Cancer

Interventions

DRUG

celecoxib

Patients receive celecoxib 400 mg administered by mouth, once daily.

DRUG

5-fluorouracil

Patients receive 400 mg/m\^2 intravenous bolus then 2400 mg/m\^2 continuous intravenous infusion over 46-48 hours.

OTHER

placebo

Patients receive placebo administered by mouth, once daily.

DRUG

oxaliplatin

Patients receive 85 mg/m\^2 intravenous over two hours.

DRUG

leucovorin

Patients receive 400 mg/m\^2 intravenous over two hours.

1. Requirements for tumor parameters 1. Histologically documented adenocarcinoma of the colon. The gross inferior (caudad) margin of the primary tumor must lie above the peritoneal reflection (i.e., patients with rectal cancer are not eligible). Surgeon confirmation that the entire tumor was above the peritoneal reflection is only required in cases where it is important to establish if the tumor is a rectal or colon primary. 2. Tumors must have been completely resected. In patients with tumor adherent to adjacent structures, en bloc R0 resection must be documented in the operative report or otherwise confirmed by the surgeon. Near or positive radial margin are not exclusions as long as en bloc resection was performed. Positive proximal margin or distal margin is an exclusion. 3. Node positive disease (N1 or N2) as designated in AJCC version 7. Either at least one pathologically confirmed positive lymph node or N1C (defined as tumor deposit(s) in the subserosa, mesentery, or nonperitonealized pericolic or perirectal tissues without regional lymph node metastases). Patients with resected stage IV disease are not eligible. 4. No evidence of residual involved lymph node disease or metastatic disease at the time of registration. 5. Patients with synchronous colon cancers are eligible and staging for stratification will be based on higher N stage of the more advanced primary tumor. However, patients with synchronous colon and rectal primary tumors are not eligible. 2. 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. 3. Patient history 1. 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. 2. No neurosensory or neuromotor toxicity ≥ grade 2 at the time of registration. 3. No known allergy to platinum compounds. 4. No prior allergic reaction or hypersensitivity to sulfonamides, celecoxib or NSAIDs. 5. 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. 6. No symptomatic pulmonary fibrosis or interstitial pneumonitis ≥ grade 2. 7. No cardiac risk factors including: * Uncontrolled high blood pressure (systolic blood pressure \> 150). * Unstable angina. * History of documented myocardial infarction or cerebrovascular accident. * New York Heart Association class III or IV heart failure. 4. 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. 5. Age and performance status 1. ECOG performance status 0, 1 or 2. 2. Age at least 18 years. 6. Required initial laboratory values 1. Granulocytes ≥ 1,500/μL 2. Platelet count ≥ 100,000/μL 3. Creatinine ≤ 1.5 times upper limit of normal (ULN) 4. Total Bilirubin ≤ 1.5 times ULN in the absence of Gilbert's disease 5. Direct bilirubin ≤ 1.5 x upper limit of normal for patients with Gilbert's syndrome

Locations (842)

University of South Alabama Mitchell Cancer Institute

Mobile, Alabama, United States

Alaska Breast Care and Surgery LLC

Anchorage, Alaska, United States

Alaska Women's Cancer Care

Anchorage, Alaska, United States

Anchorage Oncology Centre

Anchorage, Alaska, United States

Katmai Oncology Group

Anchorage, Alaska, United States

Providence Alaska Medical Center

Anchorage, Alaska, United States

Fairbanks Memorial Hospital

Fairbanks, Alaska, United States

Fowler Family Center for Cancer Care

Jonesboro, Arkansas, United States

Sutter Cancer Centers Radiation Oncology Services-Auburn

Auburn, California, United States

Alta Bates Summit Medical Center-Herrick Campus

Berkeley, California, United States

Providence Saint Joseph Medical Center-Disney Family Cancer Center

Burbank, California, United States

Mills-Peninsula Hospitals

Burlingame, California, United States

Sutter Cancer Centers Radiation Oncology Services-Cameron Park

Cameron Park, California, United States

John Muir Medical Center-Concord

Concord, California, United States

Sutter Davis Hospital

Davis, California, United States

City of Hope Comprehensive Cancer Center

Duarte, California, United States

Epic Care-Dublin

Dublin, California, United States

Bay Area Breast Surgeons Inc

Emeryville, California, United States

Epic Care Partners in Cancer Care

Emeryville, California, United States

Comprehensive Cancer Care and Research Institute of Colorado LLC

Englewood, California, United States

University Oncology Associates

Fresno, California, United States

California Cancer Center - North Fresno

Fresno, California, United States

Marin Cancer Care Inc

Greenbrae, California, United States

Marin General Hospital

Greenbrae, California, United States

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, United States

USC/Norris Comprehensive Cancer Center

Los Angeles, California, United States

Los Angeles County-USC Medical Center

Los Angeles, California, United States

Contra Costa Regional Medical Center

Martinez, California, United States

Memorial Medical Center

Modesto, California, United States

Palo Alto Medical Foundation-Camino Division

Mountain View, California, United States

Palo Alto Medical Foundation-Gynecologic Oncology

Mountain View, California, United States

Sutter Cancer Research Consortium

Novato, California, United States

Alta Bates Summit Medical Center - Summit Campus

Oakland, California, United States

Bay Area Tumor Institute

Oakland, California, United States

Hematology and Oncology Associates-Oakland

Oakland, California, United States

Saint Joseph Hospital - Orange

Orange, California, United States

UC Irvine Health-Chao Family Comprehensive Cancer Center

Orange, California, United States

Desert Regional Medical Center

Palm Springs, California, United States

Stanford Cancer Institute

Palo Alto, California, United States

Palchak David MD

Pismo Beach, California, United States

Valley Medical Oncology Consultants

Pleasanton, California, United States

Kaiser Permanente-Redwood City

Redwood City, California, United States

Kaiser Permanente-Richmond

Richmond, California, United States

Kaiser Permanente-Riverside

Riverside, California, United States

Kaiser Permanente-Roseville

Roseville, California, United States

Sutter Cancer Centers Radiation Oncology Services-Roseville

Roseville, California, United States

Sutter Roseville Medical Center

Roseville, California, United States

Sutter General Hospital

Sacramento, California, United States

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

Salinas Valley Memorial Hospital

Salinas, California, United States

Salinas Valley Memorial

Salinas, California, United States

Kaiser Permanente-San Diego Zion

San Diego, California, United States

Naval Medical Center-San Diego

San Diego, California, United States

Kaiser Permanente-San Francisco

San Francisco, California, United States

UCSF Medical Center-Mount Zion

San Francisco, California, United States

California Pacific Medical Center-Pacific Campus

San Francisco, California, United States

Veterans Affairs Medical Center-San Francisco

San Francisco, California, United States

UCSF Medical Center-Mission Bay

San Francisco, California, United States

Kaiser Permanente-Santa Teresa-San Jose

San Jose, California, United States

Santa Clara Valley Medical Center

San Jose, California, United States

Kaiser Permanente San Leandro

San Leandro, California, United States

Kaiser Permanente-San Rafael

San Rafael, California, United States

Kaiser Permanente Medical Center-Santa Clara

Santa Clara, California, United States

Palo Alto Medical Foundation-Santa Cruz

Santa Cruz, California, United States

Kaiser Permanente-Santa Rosa

Santa Rosa, California, United States

Sutter Pacific Medical Foundation

Santa Rosa, California, United States

Kaiser Permanente-South San Francisco

South San Francisco, California, United States

Saint Helena Hospital

St. Helena, California, United States

Kaiser Permanente-Stockton

Stockton, California, United States

Palo Alto Medical Foundation-Sunnyvale

Sunnyvale, California, United States

Sutter Cancer Centers Radiation Oncology Services-Vacaville

Vacaville, California, United States

Kaiser Permanente Medical Center-Vacaville

Vacaville, California, United States

Kaiser Permanente-Vallejo

Vallejo, California, United States

Sutter Solano Medical Center/Cancer Center

Vallejo, California, United States

Kaiser Permanente-Walnut Creek

Walnut Creek, California, United States

John Muir Medical Center-Walnut Creek

Walnut Creek, California, United States

Rocky Mountain Cancer Centers-Aurora

Aurora, Colorado, United States

The Medical Center of Aurora

Aurora, Colorado, United States

University of Colorado Cancer Center-Anschutz Cancer Pavilion

Aurora, Colorado, United States

Boulder Community Hospital

Boulder, Colorado, United States

Rocky Mountain Cancer Centers-Boulder

Boulder, Colorado, United States

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, United States

Rocky Mountain Cancer Centers-Penrose

Colorado Springs, Colorado, United States

Memorial Hospital Colorado Springs

Colorado Springs, Colorado, United States

Porter Adventist Hospital