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
This study has been completed.
Sponsor:
University of Miami Sylvester Comprehensive Cancer Center
Information provided by (Responsible Party):
University of Miami Sylvester Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00450736
First received: March 20, 2007
Last updated: February 18, 2013
Last verified: February 2013
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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 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by University of Miami Sylvester Comprehensive Cancer Center:
Primary Outcome Measures:
- Local failure [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Regional relapse [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Distant failure [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Progression-free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
| Enrollment: | 3 |
| Study Start Date: | March 2004 |
| Study Completion Date: | May 2009 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Single Arm | Drug: celecoxib Procedure: adjuvant therapy Radiation: radiation therapy |
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:
No publications provided
| Responsible Party: | University of Miami Sylvester Comprehensive 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: | February 18, 2013 |
| 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 May 19, 2013