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

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Trial Conditions
  • Colorectal Cancer
What is the purpose of this trial?

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.

Date & Status

Recruiting

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Both

Eligibility

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

Gender: Both
Steward Physician(s)
  • Jeffrey A. Meyerhardt, MD, MPH
Facilities
  • Holy Family Hospital - Recruiting
  • Saint Anne's Hospital - Recruiting
Trial Interventions
Drug
  • celecoxib
  • fluorouracil
  • leucovorin calcium
  • oxaliplatin
Other
  • placebo
For more information about this trial, contact

Han-Ting Lin

Phone: (978) 687-0151

Clinical Trials Office - Hudner Oncology Center at Saint Anne'

Phone: 508-674-5600 ext. 2019


Physician Researcher

Investigator Name:

  • Jeffrey A. Meyerhardt, MD, MPH

Other Information

Sponsor: Cancer and Leukemia Group B
Phase: Phase 3
Trial ID: NCT01150045
Volunteers:  Not Accepting Healthy Volunteers

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