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NCT00003156 Clinical Trial

Topotecan in Treating Patients With Recurrent or Refractory Cancer of the Uterus

Sarcoma Clinical Trial

Official title:
Evaluation of Topotecan in the Treatment of Persistent or Recurrent Carcinosarcoma (Mixed Mesodermal Tumors) of the Uterus

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00003156
Other study ID # CDR0000065948
Secondary ID GOG-130D
Status Terminated
Phase Phase 2
First received November 6, 2000
Last updated April 10, 2013
Start date June 1998

Study information
Verified date January 2006
Source Gynecologic Oncology Group
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
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 topotecan in treating patients with recurrent or refractory cancer of the uterus.

Description:

OBJECTIVES: I. Estimate the antitumor activity of topotecan in patients with recurrent or refractory carcinosarcoma of the uterus who have failed standard therapy. II. Determine the nature and degree of toxic effects of topotecan in these patients.

OUTLINE: Patients receive topotecan IV over 30 minutes daily for 5 days. Treatment repeats every 3 weeks for a minimum of 1 course in the absence of disease progression or unacceptable toxicity. Patients with complete response, partial response, or stable disease continue treatment for at least three courses. Patients are followed every 4 months for 2 years, every 6 months for 3 years, and then periodically thereafter until death.

PROJECTED ACCRUAL: Approximately 25-40 patients will be accrued for this study within 2 years.

Recruitment information / eligibility
Status Terminated
Enrollment 0
Est. completion date
Est. primary completion date October 2005
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility DISEASE CHARACTERISTICS: Histologically proven recurrent or refractory carcinosarcoma (mixed mesodermal tumors) of the uterus Measurable disease

PATIENT CHARACTERISTICS: Age: Not specified Performance Status: GOG 0-2 Life Expectancy: Not specified Hematopoietic: Platelet count at least 100,000/mm3 Absolute granulocyte count at least 1,500/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT no greater than 3 times ULN Alkaline phosphatase no greater than 3 times ULN Renal: Creatinine no greater than 1.5 mg/dL Creatinine clearance greater than 20 mL/min Other: No invasive malignancies within the past 5 years except nonmelanomatous skin cancer No significant infection

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior biologic therapy Chemotherapy: At least 3 weeks since prior chemotherapy and recovered No prior topotecan or camptothecin therapy No more than 1 prior chemotherapy regimen (either single or combination chemotherapy) Endocrine therapy: At least 3 weeks since prior endocrine therapy Radiotherapy: At least 3 weeks since prior radiotherapy and recovered Surgery: Prior surgery allowed and recovered

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• topotecan hydrochloride

Locations
Country Name City State
Canada Tom Baker Cancer Center - Calgary Calgary Alberta
United States Abington Memorial Hospital Abington Pennsylvania
United States Cancer Center of Albany Medical Center Albany New York
United States Radiation Oncology Branch Bethesda Maryland
United States University of Alabama Comprehensive Cancer Center Birmingham Alabama
United States Tufts University School of Medicine Boston Massachusetts
United States State University of New York Health Science Center at Brooklyn Brooklyn New York
United States Fletcher Allen Health Care Burlington Vermont
United States Lineberger Comprehensive Cancer Center, UNC Chapel Hill North 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 Taussig Cancer Center Cleveland Ohio
United States Ireland Cancer Center Cleveland Ohio
United States Ellis Fischel Cancer Center - Columbia Columbia Missouri
United States Arthur G. James Cancer Hospital - Ohio State University Columbus Ohio
United States Simmons Cancer Center - Dallas Dallas Texas
United States Barbara Ann Karmanos Cancer Institute Detroit Michigan
United States Duke Comprehensive Cancer Center Durham North Carolina
United States Milton S. Hershey Medical Center Hershey Pennsylvania
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 Jonsson Comprehensive Cancer Center, UCLA Los Angeles California
United States Community Hospital of Los Gatos Los Gatos California
United States North Shore University Hospital Manhasset New York
United States CCOP - Baptist Cancer Institute Memphis Tennessee
United States University of Minnesota Cancer Center Minneapolis Minnesota
United States Brookview Research, Inc. Nashville Tennessee
United States University of Oklahoma College of Medicine Oklahoma City Oklahoma
United States Chao Family Comprehensive Cancer Center Orange California
United States Fox Chase Cancer Center Philadelphia Pennsylvania
United States University of Pennsylvania Cancer Center Philadelphia Pennsylvania
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 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 - Scott and White Hospital Temple Texas
United States CCOP - Sooner State Tulsa Oklahoma
United States Walter Reed Army Medical Center Washington District of Columbia
United States Comprehensive Cancer Center of Wake Forest University Baptist Medical Center Winston-Salem North Carolina
United States CCOP - MainLine Health Wynnewood Pennsylvania

Sponsors (2)
Lead Sponsor Collaborator
Gynecologic Oncology Group National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

Miller DS, Blessing JA, Schilder J, Munkarah A, Lee YC. Phase II evaluation of topotecan in carcinosarcoma of the uterus: a Gynecologic Oncology Group study. Gynecol Oncol. 2005 Aug;98(2):217-21. — View Citation

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