Sarcoma Clinical Trial
Official title:
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
RATIONALE: Celecoxib may stop the growth of tumor cells by blocking some of the enzymes
needed for cell growth and by blocking blood flow to the tumor. Radiation therapy uses
high-energy x-rays to kill tumor cells. Giving celecoxib together with radiation therapy
after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase I trial is studying the side effects and best dose of celecoxib when
given together with radiation therapy in treating patients with stage II or stage III soft
tissue sarcoma of the arm, hand, leg, or foot that has been removed by surgery.
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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