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

Sponsor

University of Miami (Other)

Overall Status

Completed

CT.gov ID

NCT00450736

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

3 participants

Allocation:

N/A

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 :

Mar 1, 2004

Actual Primary Completion Date :

May 1, 2009

Actual Study Completion Date :

May 1, 2009

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Single Arm

Drug: celecoxib

Procedure: adjuvant therapy

Radiation: radiation therapy

Outcome Measures

Primary Outcome Measures

Local failure [3 years]
Regional relapse [3 years]
Distant failure [3 years]
Overall survival [3 years]
Progression-free survival [3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)