Paclitaxel in Treating Patients With Recurrent or Persistent Cancer of the Uterus

Sarcoma Clinical Trial

Official title:

Evaluation of Paclitaxel (Taxol) in the Treatment of Recurrent or Persistent Leiomyosarcoma of the Uterus

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00003054
• Other study ID #: CDR0000065702
• Secondary ID: GOG-131C
• Status: Terminated
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: April 11, 2018
• Start date: August 1997

Study information

• Verified date: April 2018
• Source: Gynecologic Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients with recurrent or persistent cancer of the uterus.

Description:

OBJECTIVES: I. Estimate the antitumor activity of paclitaxel in patients with metastatic or persistent leiomyosarcoma of the uterus who have failed treatment protocols of higher priority. II. Determine the nature and degree of toxic effects of paclitaxel in this group of patients.

OUTLINE: Patients receive a continuous infusion of paclitaxel once every 3 weeks over 3 hours. Patients in complete remission, partial remission, or stable disease undergo at least 3 courses of paclitaxel. Paclitaxel continues until disease progression or adverse effects prohibit further treatment. All patients are followed until death.

PROJECTED ACCRUAL: This study anticipates an annual accrual of approximately 25 patients over 2.5 years.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Est. primary completion date: July 2002
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 120 Years

Eligibility

DISEASE CHARACTERISTICS: Histologically confirmed recurrent or persistent uterine leiomyosarcoma that is refractory to curative therapy or established treatments Measurable disease required Must have failed local therapeutic measures and must be considered incurable Not eligible for GOG protocols of higher priority

PATIENT CHARACTERISTICS: Age: Not specified Performance status: GOG 0-3 Life expectancy:

Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Granulocyte count at least 1,500/mm3 Hepatic: Bilirubin no greater than 1.5 times normal SGOT and alkaline phosphatase no greater than 3 times normal Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No unstable angina within 6 months OR No myocardial infarction within 6 months Abnormal cardiac condition (e.g., bundle branch block, heart block) allowed if stable for 6 months Other: No significant infection No concomitant malignancy other than nonmelanomatous skin cancer

PRIOR CONCURRENT THERAPY: At least 3 weeks since prior therapy to malignant tumor Biologic therapy: Not specified Chemotherapy: Recovery from prior chemotherapy required No more than 1 prior chemotherapy regimen allowed No prior paclitaxel No prior chemotherapy for any malignancy from which the patient is disease-free for at least 5 years Endocrine therapy: Not specified Radiotherapy: Recovery from prior radiation therapy required No prior radiation therapy for any malignancy from which the patient is disease-free for at least 5 years Surgery: Recovery from prior surgery required

Related Conditions & MeSH terms

• Leiomyosarcoma
• Sarcoma

Intervention

Drug:
• paclitaxel

Locations

Country	Name	City	State
Canada	NCIC-Clinical Trials Group	Kingston	Ontario
United States	Abington Memorial Hospital	Abington	Pennsylvania
United States	Cancer Center of Albany Medical Center	Albany	New York
United States	CCOP - Ann Arbor Regional	Ann Arbor	Michigan
United States	Emory University Hospital - Atlanta	Atlanta	Georgia
United States	Medical College of Georgia Comprehensive Cancer Center	Augusta	Georgia
United States	Johns Hopkins Oncology Center	Baltimore	Maryland
United States	Medicine Branch	Bethesda	Maryland
United States	Radiation Oncology Branch	Bethesda	Maryland
United States	CCOP - Montana Cancer Consortium	Billings	Montana
United States	University of Alabama Comprehensive Cancer Center	Birmingham	Alabama
United States	State University of New York Health Science Center at Brooklyn	Brooklyn	New York
United States	Cooper Hospital/University Medical Center	Camden	New Jersey
United States	Lineberger Comprehensive Cancer Center, UNC	Chapel Hill	North Carolina
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Cancer Center, University of Virginia HSC	Charlottesville	Virginia
United States	Rush-Presbyterian-St. Luke's Medical Center	Chicago	Illinois
United States	University of Chicago Cancer Research Center	Chicago	Illinois
United States	Barrett Cancer Center, The University Hospital	Cincinnati	Ohio
United States	Cleveland Clinic Cancer Center	Cleveland	Ohio
United States	Ireland Cancer Center	Cleveland	Ohio
United States	Arthur G. James Cancer Hospital - Ohio State University	Columbus	Ohio
United States	Simmons Cancer Center - Dallas	Dallas	Texas
United States	University of Colorado Cancer Center	Denver	Colorado
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan
United States	Duke Comprehensive Cancer Center	Durham	North Carolina
United States	CCOP - Evanston	Evanston	Illinois
United States	Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	MBCCOP - Hawaii	Honolulu	Hawaii
United States	University of Texas - MD Anderson Cancer Center	Houston	Texas
United States	Indiana University Cancer Center	Indianapolis	Indiana
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	CCOP - Kansas City	Kansas City	Missouri
United States	CCOP - Southern Nevada Cancer Research Foundation	Las Vegas	Nevada
United States	Albert B. Chandler Medical Center, University of Kentucky	Lexington	Kentucky
United States	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California
United States	USC/Norris Comprehensive Cancer Center	Los Angeles	California
United States	North Shore University Hospital	Manhasset	New York
United States	CCOP - Baptist Cancer Institute	Memphis	Tennessee
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	University of Oklahoma College of Medicine	Oklahoma City	Oklahoma
United States	CCOP - Missouri Valley Cancer Consortium	Omaha	Nebraska
United States	Chao Family Comprehensive Cancer Center	Orange	California
United States	Women's Cancer Center	Palo Alto	California
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Kimmel Cancer Center of Thomas Jefferson University - Philadelphia	Philadelphia	Pennsylvania
United States	Pennsylvania Hospital	Philadelphia	Pennsylvania
United States	University of Pennsylvania Cancer Center	Philadelphia	Pennsylvania
United States	CCOP - Greater Phoenix	Phoenix	Arizona
United States	CCOP - Columbia River Program	Portland	Oregon
United States	University of Rochester Cancer Center	Rochester	New York
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	University of Washington Medical Center	Seattle	Washington
United States	CCOP - Upstate Carolina	Spartanburg	South Carolina
United States	CCOP - Central Illinois	Springfield	Illinois
United States	State University of New York Health Sciences Center - Stony Brook	Stony Brook	New York
United States	Tacoma General Hospital	Tacoma	Washington
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida
United States	CCOP - St. Francis Hospital/Natalie Warren Bryant Cancer Center	Tulsa	Oklahoma
United States	Vincent T. Lombardi Cancer Research Center, Georgetown University	Washington	District of Columbia
United States	Walter Reed Army Medical Center	Washington	District of Columbia
United States	Brookview Research, Inc.	Winston-Salem	North Carolina
United States	Comprehensive Cancer Center of Wake Forest University Baptist Medical Center	Winston-Salem	North Carolina
United States	University of Massachusetts Memorial Medical Center	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Gynecologic Oncology Group	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

Gallup DG, Blessing JA, Andersen W, Morgan MA; Gynecologic Oncology Group Study. Evaluation of paclitaxel in previously treated leiomyosarcoma of the uterus: a gynecologic oncology group study. Gynecol Oncol. 2003 Apr;89(1):48-51. — View Citation