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Celecoxib and 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

2014-08-27 03:39:31 | BioPortfolio

Summary

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.

Description

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.

Study Design

Primary Purpose: Treatment

Conditions

Childhood Malignant Fibrous Histiocytoma of Bone

Intervention

celecoxib, adjuvant therapy, radiation therapy

Location

University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami
Florida
United States
33136

Status

Completed

Source

University of Miami Sylvester Comprehensive Cancer Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:39:31-0400

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