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

Sarcoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00450736
• Other study ID #: 20030283
• Secondary ID: SCCC-2003053WIRB
• Status: Completed
• Phase: Phase 1
• First received: March 20, 2007
• Last updated: December 14, 2016
• Start date: March 2004
• Est. completion date: May 2009

Study information

• Verified date: December 2016
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 120 Years

Eligibility

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)

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Childhood Malignant Fibrous Histiocytoma of Bone
• Histiocytoma
• Histiocytoma, Malignant Fibrous
• Sarcoma

Intervention

Drug:
• celecoxib

Procedure:
• adjuvant therapy

Radiation:
• radiation therapy

Locations

Country	Name	City	State
United States	University of Miami Sylvester Comprehensive Cancer Center - Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local failure		3 years	No
Primary	Regional relapse		3 years	No
Primary	Distant failure		3 years	No
Primary	Overall survival		3 years	No
Primary	Progression-free survival		3 years	No