A Phase I Trial of Postoperative Radiation With Dose-Escalation of A Cox-2 Inhibitor, Celebrex™ (CELECOXIB) in Patients With Soft Tissue Sarcoma of the Extremity
- Determine the maximum tolerated dose of adjuvant celecoxib administered with
radiotherapy in patients with resected stage II or III soft tissue sarcoma of the
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
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Aaron H. Wolfson, MD
University of Miami Sylvester Comprehensive Cancer Center
United States: Food and Drug Administration
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