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

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.

DISEASE CHARACTERISTICS:

• Histologically confirmed soft tissue sarcoma of the extremity, including the following disease types:

• Liposarcoma
• Leiomyosarcoma
• Synovial cell sarcoma
• Malignant fibrous histiocytoma
• Spindle cell sarcoma
• Fibrosarcoma
• Chondrosarcoma
• Angiosarcoma
• Hemangiopericytoma
• Neurofibrosarcoma
• The following disease types are excluded:

• Kaposi's sarcoma
• Rhabdomyosarcoma
• Dermatofibrosarcoma
• Epithelioid cell sarcoma
• Ewing's sarcoma
• Osteosarcoma
• Intermediate- or high-grade tumor ≥ 5.0 cm in 1 dimension (stage II or III disease)
• Locally resected disease

• One prior wide local excision of the sarcoma in the same location of the extremity within the past 6 months allowed
• Prior neoadjuvant chemotherapy (of ≤ 3 courses), followed by a limb-sparing surgical resection of sarcoma found to have < 90% pathological tumor necrosis allowed
• Prior resection of an extremity mass that is subsequently found to be a sarcoma meeting study criteria, followed by ≤ 3 courses of chemotherapy (independent of the percentage of pathological tumor necrosis) allowed
• No evidence of nodal or distant metastases

PATIENT CHARACTERISTICS:

• Karnofsky performance status 70-100%
• WBC ≥ 3,000/mm³
• Absolute granulocyte count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Bilirubin ≤ 1.5 mg/dL
• SGPT and SGOT ≤ 2.5 times upper limit of normal (ULN)
• Creatinine ≤ 1.5 times ULN
• Calcium ≤ 1.3 times ULN
• No prior malignancy except cutaneous nonmelanomatous skin cancer, carcinoma in situ of the cervix, or other cancer for which the patient has been disease-free for at least 5 years
• No history of allergic reaction to sulfonamides or NSAIDs
• No known hypersensitivity to celecoxib or any component of its formulation
• No known HIV positivity
• No known coronary artery disease
• No cardiac event of any kind within the past 6 months
• No concurrent unstable cardiac status
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• No prior radiotherapy to the extremity requiring radiation for this study
• No prior systemic chemotherapy for a malignant tumor
• No concurrent dilantin or lithium carbonate
• No other concurrent prescription or over-the-counter nonsteroidal anti-inflammatory agents (NSAIDs)