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

  • Study type:

    Interventional What is this?

    Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Study phase:

    III What is this?

    During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

Study IDs

  • Site IRB:

    • Jacksonville, Florida: 10-005499
    • Rochester, Minnesota: 10-005499
  • NCT ID:

    NCT01150045
  • Sponsor Protocol Number:

    CALGB 80702

About this study

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.

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the colon
    • Stage III disease
    • The gross inferior (caudal) margin of the primary tumor must lie above the peritoneal reflection
      • 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
      • 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
    • Patients with resected stage IV disease are not eligible
  • 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)
  • 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, 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, 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 ≥ 2 times per week on average or aspirin at > 325 mg ≥ 3 times per week on average
    • Low-dose aspirin not exceeding 100 mg/day allowed
    • Patients who agree to stop regular NSAIDs or higher-dose aspirin are eligble and no wash-out period is required

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Axel Grothey, M.D.

Closed for Enrollment

Cancer Center Clinical Trials Referral Office

855-776-0015

Rochester, Minn.

Mayo Clinic principal investigator

Axel Grothey, M.D.

Closed for Enrollment

Cancer Center Clinical Trials Referral Office

855-776-0015