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 - Full Text View

Sponsor:	University of Miami Sylvester Comprehensive Cancer Center
Information provided by:	University of Miami Sylvester Comprehensive Cancer Center
ClinicalTrials.gov Identifier:	NCT00450736

Purpose

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	Intervention	Phase
Childhood Malignant Fibrous Histiocytoma of Bone Sarcoma	Drug: celecoxib Procedure: adjuvant therapy Radiation: radiation therapy	Phase I

Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Foot Health Soft Tissue Sarcoma

Drug Information available for: Celecoxib

U.S. FDA Resources

Further study details as provided by University of Miami Sylvester Comprehensive Cancer Center:

Primary Outcome Measures:

Local failure [ Designated as safety issue: No ]
Regional relapse [ Designated as safety issue: No ]
Distant failure [ Designated as safety issue: No ]
Overall survival [ Designated as safety issue: No ]
Progression-free survival [ Designated as safety issue: No ]

Estimated Enrollment:	24
Study Start Date:	March 2004
Study Completion Date:	May 2009
Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00450736

Locations

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

Sponsors and Collaborators

University of Miami Sylvester Comprehensive Cancer Center

Investigators

Study Chair:

Aaron H. Wolfson, MD

University of Miami Sylvester Comprehensive Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Aaron Wolfson, MD, University of Miami Sylvester Comprehsensive Cancer Center
ClinicalTrials.gov Identifier:	NCT00450736 History of Changes
Other Study ID Numbers:	EPROST-20030283, SCCC-2003053, WIRB-20051240
Study First Received:	March 20, 2007
Last Updated:	April 15, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Miami Sylvester Comprehensive Cancer Center:

chondrosarcoma
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:

Histiocytoma
Fibrosis
Histiocytoma, Benign Fibrous
Histiocytoma, Malignant Fibrous
Sarcoma
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Pathologic Processes
Celecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors

Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Central Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on February 09, 2012