A Phase III Trial of 6 Versus 12 Treatments of Adjuvant FOLFOX Plus Celecoxib or Placebo for Patients with Resected Stage III Colon Cancer.
||Peter Kozuch, MD
| Time frame of study:
|Location of Study:
Mount Sinai Beth Israel
St.Luke's-Mount Sinai Roosevelt
Continuum Cancer Research Program
In this study, we will evaluate the effects (good and bad) of an oral drug called celecoxib when given in combination with FOLFOX chemotherapy One of the common combinations of chemotherapy drugs used to treat your type of cancer includes 5-fluorouracil (also called 5-FU), leucovorin and oxaliplatin, and is also called “FOLFOX”. At the present time, the Food and Drug Administration (FDA) has approved each of these drugs as treatment for colon cancer. FOLFOX is a standard treatment used to prevent colon cancer from coming back (recurrence). Celecoxib is approved by the FDA to treat arthritis. It is also approved to help prevent colon polyps in families with a genetic risk for colon cancer. This study will also look at whether receiving FOLFOX chemotherapy for 6 treatments (12 weeks) is as good as 12 treatments (24 weeks) in preventing recurrence of colon cancer.
Subjects eligible for this study will receive 1 of 4 treatments:
ARM A: 12 cycles of FOLFOX + placebo daily
ARM B: 12 cycles of FOLFOX + celecoxib 400mg daily
ARM C: 6 cycles of FOLFOX + placebo daily
ARM D: 6 cycles of FOLFOX + celecoxib 400mg daily
- Subjects must have histologically documented adenocarcinoma of the colon
- Subjects must be at least 18 years old.
- Subjects cannot be taking any dose or aspirin at more than 325 mg at least three times per week.