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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

Phase 1
18 Years
Not Enrolling
Childhood Malignant Fibrous Histiocytoma of Bone, Sarcoma

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Trial Information

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


- Determine the maximum tolerated dose of adjuvant celecoxib administered with
radiotherapy in patients with resected stage II or III soft tissue sarcoma of the

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

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.

Inclusion Criteria


- 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

- 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


- 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


- 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)

Type of Study:


Study Design:

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

Outcome Measure:

Local failure

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Aaron H. Wolfson, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Miami Sylvester Comprehensive Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

March 2004

Completion Date:

May 2009

Related Keywords:

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



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