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)