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

Inclusion 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