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

Sponsor

Gynecologic Oncology Group (Other)

Overall Status

Terminated

CT.gov ID

NCT00003156

Collaborator

National Cancer Institute (NCI) (NIH)

Locations

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Sarcoma	Drug: topotecan hydrochloride	Phase 2

Detailed 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.

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 1998

Actual Primary Completion Date :

Oct 1, 2005

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama Comprehensive Cancer Center	Birmingham	Alabama	United States	35294
2	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California	United States	90095-1781
3	Community Hospital of Los Gatos	Los Gatos	California	United States	95032
4	Chao Family Comprehensive Cancer Center	Orange	California	United States	92868
5	Walter Reed Army Medical Center	Washington	District of Columbia	United States	20307-5000
6	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida	United States	33612
7	Rush-Presbyterian-St. Luke's Medical Center	Chicago	Illinois	United States	60612
8	University of Chicago Cancer Research Center	Chicago	Illinois	United States	60637
9	Indiana University Cancer Center	Indianapolis	Indiana	United States	46202-5265
10	University of Iowa Hospitals and Clinics	Iowa City	Iowa	United States	52242
11	Radiation Oncology Branch	Bethesda	Maryland	United States	20892
12	Tufts University School of Medicine	Boston	Massachusetts	United States	02111
13	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan	United States	48201
14	University of Minnesota Cancer Center	Minneapolis	Minnesota	United States	55455
15	University of Mississippi Medical Center	Jackson	Mississippi	United States	39216-4505
16	Ellis Fischel Cancer Center - Columbia	Columbia	Missouri	United States	65203
17	CCOP - Kansas City	Kansas City	Missouri	United States	64131
18	Washington University School of Medicine	Saint Louis	Missouri	United States	63110
19	Cancer Center of Albany Medical Center	Albany	New York	United States	12208
20	State University of New York Health Science Center at Brooklyn	Brooklyn	New York	United States	11203
21	North Shore University Hospital	Manhasset	New York	United States	11030
22	State University of New York Health Sciences Center - Stony Brook	Stony Brook	New York	United States	11790-7775
23	Lineberger Comprehensive Cancer Center, UNC	Chapel Hill	North Carolina	United States	27599-7295
24	Duke Comprehensive Cancer Center	Durham	North Carolina	United States	27710
25	Comprehensive Cancer Center of Wake Forest University Baptist Medical Center	Winston-Salem	North Carolina	United States	27157-1082
26	Barrett Cancer Center, The University Hospital	Cincinnati	Ohio	United States	45219
27	Ireland Cancer Center	Cleveland	Ohio	United States	44106-5065
28	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio	United States	44195
29	Arthur G. James Cancer Hospital - Ohio State University	Columbus	Ohio	United States	43210
30	University of Oklahoma College of Medicine	Oklahoma City	Oklahoma	United States	73190
31	CCOP - Sooner State	Tulsa	Oklahoma	United States	74136
32	Abington Memorial Hospital	Abington	Pennsylvania	United States	19001
33	Milton S. Hershey Medical Center	Hershey	Pennsylvania	United States	17033
34	University of Pennsylvania Cancer Center	Philadelphia	Pennsylvania	United States	19104
35	Fox Chase Cancer Center	Philadelphia	Pennsylvania	United States	19111
36	CCOP - MainLine Health	Wynnewood	Pennsylvania	United States	19096
37	CCOP - Upstate Carolina	Spartanburg	South Carolina	United States	29303
38	CCOP - Baptist Cancer Institute	Memphis	Tennessee	United States	38117
39	Brookview Research, Inc.	Nashville	Tennessee	United States	37203
40	Simmons Cancer Center - Dallas	Dallas	Texas	United States	75235-9154
41	CCOP - Scott and White Hospital	Temple	Texas	United States	76508
42	Fletcher Allen Health Care	Burlington	Vermont	United States	05401
43	Cancer Center, University of Virginia HSC	Charlottesville	Virginia	United States	22908
44	University of Washington Medical Center	Seattle	Washington	United States	98195-6043
45	Tacoma General Hospital	Tacoma	Washington	United States	98405
46	Tom Baker Cancer Center - Calgary	Calgary	Alberta	Canada	T2N 4N2