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| ID | Type | Description | Link |
|---|---|---|---|
| SCCC-2003053 | Other Identifier | University of Miami Sylvester Comprehensive Cancer Center | |
| WIRB-20051240 | Other Identifier | Western Institution Reviw Board |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| celecoxib | Drug |
| ||
| adjuvant therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Local failure | 3 years | |
| Regional relapse | 3 years | |
| Distant failure | 3 years | |
| Overall survival | 3 years | |
| Progression-free survival | 3 years |
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DISEASE CHARACTERISTICS:
Histologically confirmed soft tissue sarcoma of the extremity, including the following disease types:
The following disease types are excluded:
Intermediate- or high-grade tumor ≥ 5.0 cm in 1 dimension (stage II or III disease)
Locally resected disease
No evidence of nodal or distant metastases
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Aaron H. Wolfson, MD | University of Miami Sylvester Comprehensive Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami Sylvester Comprehensive Cancer Center - Miami | Miami | Florida | 33136 | United States |
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|
| radiation therapy | Radiation |
|
| ID | Term |
|---|---|
| D012509 | Sarcoma |
| D002813 | Chondrosarcoma |
| D006394 | Hemangiosarcoma |
| D005354 | Fibrosarcoma |
| D007890 | Leiomyosarcoma |
| D008080 | Liposarcoma |
| D018319 | Neurofibrosarcoma |
| D013584 | Sarcoma, Synovial |
| D051677 | Histiocytoma, Malignant Fibrous |
| C562740 | Hemangiopericytoma, Malignant |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009372 | Neoplasms, Connective Tissue |
| D009383 | Neoplasms, Vascular Tissue |
| D018218 | Neoplasms, Fibrous Tissue |
| D009379 | Neoplasms, Muscle Tissue |
| D018205 | Neoplasms, Adipose Tissue |
| D009455 | Neurofibroma |
| D018317 | Nerve Sheath Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D010524 | Peripheral Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009422 | Nervous System Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D051642 | Histiocytoma |
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| ID | Term |
|---|---|
| D000068579 | Celecoxib |
| D017024 | Chemotherapy, Adjuvant |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
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