Clinical trial NCT00450736: 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Childhood Malignant Fibrous Histiocytoma of Bone
Sarcoma
Keywords: 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
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2007-03-22
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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)

Primary outcomes:
measure: Local failure
timeFrame: 3 years
measure: Regional relapse
timeFrame: 3 years
measure: Distant failure
timeFrame: 3 years
measure: Overall survival
timeFrame: 3 years
measure: Progression-free survival
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Sylvester Comprehensive Cancer Center - Miami
state: Florida
Study officials:
affiliation: University of Miami Sylvester Comprehensive Cancer Center
name: Aaron H. Wolfson, MD
role: STUDY_CHAIR
References: