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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00450736
Recruitment Status : Completed
First Posted : March 22, 2007
Last Update Posted : December 15, 2016
Information provided by (Responsible Party):
University of Miami

Brief 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.

Condition or disease Intervention/treatment Phase
Childhood Malignant Fibrous Histiocytoma of Bone Sarcoma Drug: celecoxib Procedure: adjuvant therapy Radiation: radiation therapy Phase 1

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : March 2004
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Arm Intervention/treatment
Experimental: Single Arm Drug: celecoxib
Procedure: adjuvant therapy
Radiation: radiation therapy

Primary Outcome Measures :
  1. Local failure [ Time Frame: 3 years ]
  2. Regional relapse [ Time Frame: 3 years ]
  3. Distant failure [ Time Frame: 3 years ]
  4. Overall survival [ Time Frame: 3 years ]
  5. Progression-free survival [ Time Frame: 3 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00450736

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United States, Florida
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
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Study Chair: Aaron H. Wolfson, MD University of Miami Sylvester Comprehensive Cancer Center

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Responsible Party: University of Miami Identifier: NCT00450736     History of Changes
Other Study ID Numbers: 20030283
SCCC-2003053 ( Other Identifier: University of Miami Sylvester Comprehensive Cancer Center )
WIRB-20051240 ( Other Identifier: Western Institution Reviw Board )
First Posted: March 22, 2007    Key Record Dates
Last Update Posted: December 15, 2016
Last Verified: December 2016
Keywords provided by University of Miami:
adult angiosarcoma
adult fibrosarcoma
adult leiomyosarcoma
adult liposarcoma
adult neurofibrosarcoma
adult synovial sarcoma
childhood angiosarcoma
childhood fibrosarcoma
childhood leiomyosarcoma
childhood liposarcoma
childhood neurofibrosarcoma
childhood synovial sarcoma
nonmetastatic childhood soft tissue sarcoma
stage II adult soft tissue sarcoma
stage III adult soft tissue sarcoma
adult malignant fibrous histiocytoma
adult malignant hemangiopericytoma
childhood malignant hemangiopericytoma
localized childhood malignant fibrous histiocytoma of bone
Additional relevant MeSH terms:
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Histiocytoma, Benign Fibrous
Histiocytoma, Malignant Fibrous
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action