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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by National Cancer Institute (NCI)
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01150045
First received: June 23, 2010
Last updated: February 17, 2013
Last verified: February 2013

June 23, 2010
February 17, 2013
June 2010
December 2019   (final data collection date for primary outcome measure)
Disease-free survival [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01150045 on ClinicalTrials.gov Archive Site
  • Recurrence-free survival [ Designated as safety issue: No ]
  • Overall survival at 3 years [ Designated as safety issue: No ]
  • Toxicity of celecoxib [ Designated as safety issue: Yes ]
  • Cardiovascular-specific events [ Designated as safety issue: Yes ]
  • Differences in toxicity, particularly cumulative peripheral neuropathy, of 6 vs 12 courses of FOLFOX [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Oxaliplatin, Leucovorin Calcium, and Fluorouracil With or Without Celecoxib in Treating Patients With Stage III Colon Cancer Previously Treated With Surgery
A Phase III Trial of 6 Versus 12 Treatments of Adjuvant FOLFOX Plus Celecoxib or Placebo for Patients With Resected Stage III Colon Cancer

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.

OBJECTIVES:

Primary

  • To compare disease-free survival of patients with resected stage III colon cancer treated with adjuvant FOLFOX chemotherapy comprising oxaliplatin, fluorouracil, and leucovorin calcium with versus without celecoxib.

Secondary

  • To contribute to an international prospective pooled analysis comparing disease-free survival of patients treated with these regimens.
  • To compare overall survival at 3 years of patients treated with these regimens.
  • To contribute to an international prospective pooled analysis comparing disease-free survival of patients treated with 6 versus 12 courses of FOLFOX chemotherapy.
  • To assess toxicities of celecoxib as maintenance adjuvant therapy in these patients.
  • To assess differences in cardiovascular-specific events in patients treated with versus without celecoxib.
  • To evaluate differences in toxicities, particularly cumulative peripheral neuropathy, in patients treated with 6 versus 12 courses of FOLFOX chemotherapy.

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.

NOTE: *Patients with N1c-only disease (i.e., no positive nodes but N1c disease by AJCC 7) should be stratified to 1-3 nodes.

  • Arm I: Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46-48 hours (FOLFOX) on day 1. Patients also receive oral celecoxib once daily on days 1-14 beginning on day 1 of course 2 of FOLFOX. Courses repeat every 14 days for 12 courses in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive FOLFOX as in arm I and oral placebo once daily on days 1-14 beginning on day 1 of course 2. Courses repeat every 14 days for 12 courses in the absence of disease progression or unacceptable toxicity.
  • Arm III: Patients receive FOLFOX and celecoxib as in arm I. Courses repeat every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
  • Arm IV: Patients receive FOLFOX and placebo as in arm II. Courses repeat every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.

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.

After completion of study therapy, patients are followed up every 3 months for 1 year, every 6 months for years 2-3, and then annually for 3 years.

Interventional
Phase 3
Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Treatment
Colorectal Cancer
  • Drug: celecoxib
    Given orally
  • Drug: fluorouracil
    Given IV
  • Drug: leucovorin calcium
    Given IV
  • Drug: oxaliplatin
    Given IV
  • Other: placebo
    Given orally
  • Experimental: Arm I
    Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46-48 hours (FOLFOX) on day 1. Patients also receive oral celecoxib once daily on days 1-14 beginning on day 1 of course 2. Courses repeat every 14 days for 12 courses in the absence of disease progression or unacceptable toxicity.
    Interventions:
    • Drug: celecoxib
    • Drug: fluorouracil
    • Drug: leucovorin calcium
    • Drug: oxaliplatin
  • Placebo Comparator: Arm II
    Patients receive FOLFOX as in arm I and oral placebo once daily on days 1-14 beginning on day 1 of course 2. Courses repeat every 14 days for 12 courses in the absence of disease progression or unacceptable toxicity.
    Interventions:
    • Drug: fluorouracil
    • Drug: leucovorin calcium
    • Drug: oxaliplatin
    • Other: placebo
  • Experimental: Arm III
    Patients receive FOLFOX and celecoxib as in arm I. Courses repeat every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
    Interventions:
    • Drug: celecoxib
    • Drug: fluorouracil
    • Drug: leucovorin calcium
    • Drug: oxaliplatin
  • Placebo Comparator: Arm IV
    Patients receive FOLFOX and placebo as in arm II. Courses repeat every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
    Interventions:
    • Drug: fluorouracil
    • Drug: leucovorin calcium
    • Drug: oxaliplatin
    • Other: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2500
Not Provided
December 2019   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
United States,   Canada
 
NCT01150045
CDR0000675693, CALGB-80702
Not Provided
Monica M. Bertagnolli, Cancer and Leukemia Group B
Cancer and Leukemia Group B
National Cancer Institute (NCI)
Principal Investigator: Jeffrey A. Meyerhardt, MD, MPH Dana-Farber Cancer Institute
National Cancer Institute (NCI)
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP