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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
Trial ID: NCT01150045
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.
A Phase III Trial of 6 Versus 12 Treatments of Adjuvant FOLFOX Plus Celecoxib or Placebo for Patients With Resected Stage III Colon Cancer
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
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
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
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
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