OBJECTIVES:
* Determine the maximum tolerated dose of adjuvant celecoxib administered with radiotherapy in patients with resected stage II or III soft tissue sarcoma of the extremity.
OUTLINE: This is a dose-escalation study of celecoxib.
Beginning within 10 weeks of the most recent resection, patients undergo standard radiotherapy once daily, 5 days a week, in weeks 1-7. Patients also receive oral celecoxib twice daily in weeks 1-7 in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of celecoxib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity. A maximum of 6 patients are treated at the MTD.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.