Phase III Trial of 6 versus 12 Treatments of Adjuvant FOLFOX Plus Celecoxib or Placebo for Patients with Resected Stage III Colon Cancer
One of the purposes of this study is to determine if giving patients celecoxib and the standard chemotherapy (FOLFOX) decreases the risk of colon cancer recurrence.
This study is also looking at whether receiving FOLFOX (5-fluorouracil/5-FU, leucovorin, oxaliplatin) chemotherapy for 6 treatments is as good as 12 treatments in preventing colon cancer recurrence.
Celecoxib is a non-steroidal anti-inflammatory drug used to treat patients with arthritis and other painful conditions. Studies have shown that celecoxib may reduce the chance of getting polyps (abnormal growths in the colon that may turn to cancer).
Eligibility criteria include the following:
- A histologically confirmed diagnosis of adenocarcinoma of the colon (patients must not have rectal cancer)
- Complete resection of the tumor
- Node positive disease
- Must not have stage IV disease
- Must not have used NSAIDs at any dose or aspirin 325 mg more than two times per week on average (low dose aspirin is permitted)
- Must not have concurrent or previous malignancy
- Must not have a grade 2 or higher neuropathy
- Must not have a history of upper GI ulcer, bleeding or perforation within the past three years
- Must not have pulmonary fibrosis or interstitial pneumonitis
- Must not have cardiac risk factors (hypertension, unstable angina, heart attack, stroke)
- Must be at least 18 years of age
- Must not be pregnant or nursing
Final eligibility for a clinical trial is determined by the health professionals conducting the trial.
Patients will be randomly assigned to one of four groups:
ARM A: 12 cycles of FOLFOX + Placebo daily
ARM B: 12 cycles of FOLFOX + Celecoxib daily
ARM C: 6 cycles of FOLFOX + Placebo daily
ARM D: 6 cycles of FOLFOX + Celecoxib daily
Celecoxib/placebo will continue for 3 years or until unacceptable toxicity.
The study doctor will follow patients at a minimum of every 6 months for up to 6 years after the study was started. During the actual treatment period, the patient will be followed more frequently based on the protocol requirements.