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

December 14, 2016 updated by: University of Miami

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

3

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami Sylvester Comprehensive Cancer Center - Miami

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 118 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 3 years
3 years
Progression-free survival
Time Frame: 3 years
3 years
Local failure
Time Frame: 3 years
3 years
Regional relapse
Time Frame: 3 years
3 years
Distant failure
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Investigators

  • Study Chair: Aaron H. Wolfson, MD, University of Miami Sylvester Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2004

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

March 20, 2007

First Submitted That Met QC Criteria

March 20, 2007

First Posted (Estimate)

March 22, 2007

Study Record Updates

Last Update Posted (Estimate)

December 15, 2016

Last Update Submitted That Met QC Criteria

December 14, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20030283
  • SCCC-2003053 (Other Identifier: University of Miami Sylvester Comprehensive Cancer Center)
  • WIRB-20051240 (Other Identifier: Western Institution Reviw Board)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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