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Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started

Description

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

Details

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:

  1. To contribute to an international prospective pooled analysis that will compare disease-free survival of patients with stage III colon cancer randomized to 6 treatments of adjuvant FOLFOX chemotherapy or 12 treatments of adjuvant FOLFOX chemotherapy.
  2. To compare overall 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.
  3. To contribute to an international prospective pooled analysis that will compare overall survival of patients with stage III colon cancer randomized to 6 treatments of adjuvant FOLFOX chemotherapy or 12 treatments of adjuvant FOLFOX chemotherapy or 12 treatments of adjuvant FOLFOX chemotherapy.
  4. To assess toxicities of celecoxib as maintenance adjuvant therapy in patients with stage III colon cancer.
  5. To assess differences in cardiovascular-specific events with celecoxib versus placebo in a population of stage III colon cancer survivors.
  6. To evaluate differences in toxicities, particularly cumulative peripheral neuropathy, for patients treated with 6 treatments of FOLFOX compared to those treated with 12 treatments of FOLFOX.

After completion of study therapy, patients are followed up every 6 months for up to 6 years.

Keywords

Colorectal Cancer adenocarcinoma of the colon stage III colon cancer Oxaliplatin Fluorouracil Celecoxib

Eligibility

For people ages 18 years and up

  1. Requirements for tumor parameters
  2. 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.
  3. 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.
  4. 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.
  5. No evidence of residual involved lymph node disease or metastatic disease at the time of registration.
  6. 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.
  7. 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.

  1. Patient history
  2. 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.
  3. No neurosensory or neuromotor toxicity ≥ grade 2 at the time of registration.
  4. No known allergy to platinum compounds.
  5. No prior allergic reaction or hypersensitivity to sulfonamides, celecoxib or NSAIDs.
  6. 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.
  7. No symptomatic pulmonary fibrosis or interstitial pneumonitis ≥ grade 2.
  8. No cardiac risk factors including:
  9. Uncontrolled high blood pressure (systolic blood pressure > 150).
  10. Unstable angina.
  11. History of documented myocardial infarction or cerebrovascular accident.
  12. New York Heart Association class III or IV heart failure.
  13. 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.

  1. Age and performance status
  2. ECOG performance status 0, 1 or 2.
  3. Age at least 18 years.
  4. Required initial laboratory values
  5. Granulocytes ≥ 1,500/μL
  6. Platelet count ≥ 100,000/μL
  7. Creatinine ≤ 1.5 times upper limit of normal (ULN)
  8. Total Bilirubin ≤ 1.5 times ULN in the absence of Gilbert's disease
  9. Direct bilirubin ≤ 1.5 x upper limit of normal for patients with Gilbert's syndrome

Locations

  • University Oncology Associates
    Fresno, California, 93701, United States
  • Kaiser Permanente-San Francisco
    San Francisco, California, 94115, United States
  • California Pacific Medical Center-Pacific Campus
    San Francisco, California, 94118, United States
  • Veterans Affairs Medical Center-San Francisco
    San Francisco, California, 94121, United States
  • California Cancer Center - North Fresno
    Fresno, California, 93720, United States
  • Kaiser Permanente-South San Francisco
    South San Francisco, California, 94080, United States
  • Bay Area Breast Surgeons Inc
    Emeryville, California, 94608, United States
  • Epic Care Partners in Cancer Care
    Emeryville, California, 94608, United States
  • Alta Bates Summit Medical Center - Summit Campus
    Oakland, California, 94609, United States
  • Bay Area Tumor Institute
    Oakland, California, 94609, United States
  • Hematology and Oncology Associates-Oakland
    Oakland, California, 94609, United States
  • Alta Bates Summit Medical Center-Herrick Campus
    Berkeley, California, 94704, United States
  • Marin Cancer Care Inc
    Greenbrae, California, 94904, United States
  • Marin General Hospital
    Greenbrae, California, 94904, United States
  • Kaiser Permanente-Richmond
    Richmond, California, 94801, United States
  • Mills-Peninsula Hospitals
    Burlingame, California, 94010, United States
  • Palo Alto Medical Foundation-Sunnyvale
    Sunnyvale, California, 94806, United States
  • Kaiser Permanente San Leandro
    San Leandro, California, 94577, United States
  • Kaiser Permanente-San Rafael
    San Rafael, California, 94903, United States
  • Contra Costa Regional Medical Center
    Martinez, California, 94553, United States
  • Kaiser Permanente-Redwood City
    Redwood City, California, 94063, United States
  • Kaiser Permanente-Walnut Creek
    Walnut Creek, California, 94596, United States
  • Sutter Cancer Research Consortium
    Novato, California, 94945, United States
  • John Muir Medical Center-Walnut Creek
    Walnut Creek, California, 94598, United States
  • Stanford Cancer Institute
    Palo Alto, California, 94304, United States
  • Kaiser Permanente-Vallejo
    Vallejo, California, 94589, United States
  • Sutter Solano Medical Center/Cancer Center
    Vallejo, California, 94589, United States
  • Epic Care-Dublin
    Dublin, California, 94568, United States
  • Valley Medical Oncology Consultants
    Pleasanton, California, 94588, United States
  • Palo Alto Medical Foundation-Camino Division
    Mountain View, California, 94040, United States
  • Palo Alto Medical Foundation-Gynecologic Oncology
    Mountain View, California, 94040, United States
  • Kaiser Permanente Medical Center-Santa Clara
    Santa Clara, California, 95051, United States
  • Santa Clara Valley Medical Center
    San Jose, California, 95128, United States
  • Sutter Cancer Centers Radiation Oncology Services-Vacaville
    Vacaville, California, 95687, United States
  • Kaiser Permanente Medical Center-Vacaville
    Vacaville, California, 95688, United States
  • Saint Helena Hospital
    Saint Helena, California, 95474, United States
  • Kaiser Permanente-Santa Teresa-San Jose
    San Jose, California, 95119, United States
  • Kaiser Permanente-Santa Rosa
    Santa Rosa, California, 95403, United States
  • Sutter Pacific Medical Foundation
    Santa Rosa, California, 95403, United States
  • Palo Alto Medical Foundation-Santa Cruz
    Santa Cruz, California, 95065, United States
  • Kaiser Permanente-Stockton
    Stockton, California, 95210, United States
  • Sutter Davis Hospital
    Davis, California, 95616, United States
  • University of California Davis Comprehensive Cancer Center
    Sacramento, California, 95817, United States
  • Sutter General Hospital
    Sacramento, California, 95816, United States
  • Memorial Medical Center
    Modesto, California, 95355, United States
  • Salinas Valley Memorial Hospital
    Salinas, California, 93901, United States
  • Salinas Valley Memorial
    Salinas, California, 93901, United States
  • Kaiser Permanente-Roseville
    Roseville, California, 95661, United States
  • Sutter Cancer Centers Radiation Oncology Services-Roseville
    Roseville, California, 95661, United States
  • Sutter Roseville Medical Center
    Roseville, California, 95661, United States
  • Sutter Cancer Centers Radiation Oncology Services-Cameron Park
    Cameron Park, California, 95682, United States
  • Sutter Cancer Centers Radiation Oncology Services-Auburn
    Auburn, California, 95603, United States
  • Palchak David MD
    Pismo Beach, California, 93449, United States
  • John Muir Medical Center-Concord
    Concord, California, 95420, United States
  • Providence Saint Joseph Medical Center-Disney Family Cancer Center
    Burbank, California, 91505, United States
  • Kaiser Permanente Los Angeles Medical Center
    Los Angeles, California, 90027, United States
  • USC/Norris Comprehensive Cancer Center
    Los Angeles, California, 90033-0804, United States
  • Los Angeles County-USC Medical Center
    Los Angeles, California, 90033, United States
  • City of Hope Comprehensive Cancer Center
    Duarte, California, 91010, United States
  • Saint Joseph Hospital - Orange
    Orange, California, 92868, United States
  • UC Irvine Health-Chao Family Comprehensive Cancer Center
    Orange, California, 92868, United States
  • Kaiser Permanente-Riverside
    Riverside, California, 92505, United States
  • 21st Century Oncology-Vegas Tenaya
    Las Vegas, Nevada, 89128, United States
  • Cancer and Blood Specialists-Shadow
    Las Vegas, Nevada, 89128, United States
  • Cancer and Blood Specialists-Tenaya
    Las Vegas, Nevada, 89128, United States
  • HealthCare Partners Medical Group Oncology/Hematology-Tenaya
    Las Vegas, Nevada, 89128, United States
  • 21st Century Oncology-Fort Apache
    Las Vegas, Nevada, 89148, United States
  • Cancer and Blood Specialists-Fort Apache
    Las Vegas, Nevada, 89148, United States
  • HealthCare Partners Medical Group Oncology/Hematology-San Martin
    Las Vegas, Nevada, 89113, United States
  • University Medical Center of Southern Nevada
    Las Vegas, Nevada, 89102, United States
  • Cancer and Blood Specialists-Henderson
    Las Vegas, Nevada, 89106, United States
  • 21st Century Oncology
    Las Vegas, Nevada, 89109, United States
  • Cancer Therapy and Integrative Medicine
    Las Vegas, Nevada, 89121, United States
  • 21st Century Oncology-Henderson
    Henderson, Nevada, 89074, United States
  • Desert Regional Medical Center
    Palm Springs, California, 92262, United States

Details

Status
in progress, not accepting new patients
Start Date
Sponsor
Alliance for Clinical Trials in Oncology
ID
NCT01150045
Phase
Phase 3
Lead Scientist
Alan Venook
Study Type
Interventional
Last Updated
June 1, 2017