Combination Chemotherapy in Treating Patients With Recurrent or Advanced Cancer of the Uterus

Sponsor

Gynecologic Oncology Group (Other)

Overall Status

Terminated

CT.gov ID

NCT00002993

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Locations

0.6

Patients Per Site

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. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with mitomycin, doxorubicin, and cisplatin in treating patients with recurrent or advanced cancer of the uterus.

Condition or Disease	Intervention/Treatment	Phase
Sarcoma	Drug: cisplatin Drug: doxorubicin hydrochloride Drug: mitomycin C	Phase 2

Detailed Description

OBJECTIVES: I. Estimate the antitumor activity of the combination of mitomycin, doxorubicin, and cisplatin (MAP) in patients with recurrent or advanced uterine sarcomas. II. Determine the nature and degree of toxicity of MAP chemotherapy in this cohort of patients.

OUTLINE: Patients receive IV doxorubicin, mitomycin, and cisplatin over 3 hours once every 3 weeks, for a minimum of 1 course. Patients who have complete response, partial response, or stable disease will continue for at least 3 courses. If side effects are not severe, patients may remain on the study regimen at the investigator's discretion for a maximum of 6 courses. All patients are followed until death.

PROJECTED ACCRUAL: The first stage of accrual is anticipated to accrue 20 evaluable patients in approximately 12 months. If indicated, a second stage will accrue approximately 10 evaluable patients.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Primary Purpose:

Treatment

Official Title:

Evaluation of Mitomycin, Doxorubicin and Cisplatin in the Treatment of Recurrent or Advanced Uterine Sarcomas

Study Start Date :

Aug 1, 1997

Actual Primary Completion Date :

Jan 1, 2000

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 confirmed advanced, persistent, or recurrent uterine sarcoma Documented disease progression after local therapy Measurable disease consisting of abdominal, pelvic, chest, or other masses that can be defined in at least two dimensions by palpation, x-ray, computed tomography or ultrasound

PATIENT CHARACTERISTICS: Age: No age specified Performance status: Karnofsky 50%-100% Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times normal SGOT no greater than 3 times normal Alkaline phosphatase no greater than 3 times normal Renal: Creatinine no greater than 1.5 times normal Cardiovascular: Ejection fraction within institutional normal limits Pulmonary: Not specified Other: No active infection No concurrent second malignancy other than nonmelanoma skin cancer Must be disease free of any prior malignancy for at least 5 years and not received any treatments with chemotherapy or radiation therapy for that malignancy

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 6 weeks since radiotherapy Recovered from effects of radiotherapy Surgery: Recovered from effects of surgery

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama Comprehensive Cancer Center	Birmingham	Alabama	United States	35294
2	USC/Norris Comprehensive Cancer Center	Los Angeles	California	United States	90033-0800
3	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California	United States	90095-1781
4	Chao Family Comprehensive Cancer Center	Orange	California	United States	92868
5	Women's Cancer Center	Palo Alto	California	United States	94304
6	University of Colorado Cancer Center	Denver	Colorado	United States	80262
7	Vincent T. Lombardi Cancer Research Center, Georgetown University	Washington	District of Columbia	United States	20007
8	Walter Reed Army Medical Center	Washington	District of Columbia	United States	20307-5000
9	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida	United States	33612
10	Emory University Hospital - Atlanta	Atlanta	Georgia	United States	30322
11	MBCCOP - Hawaii	Honolulu	Hawaii	United States	96813
12	Rush-Presbyterian-St. Luke's Medical Center	Chicago	Illinois	United States	60612
13	University of Chicago Cancer Research Center	Chicago	Illinois	United States	60637
14	Indiana University Cancer Center	Indianapolis	Indiana	United States	46202-5265
15	University of Iowa Hospitals and Clinics	Iowa City	Iowa	United States	52242
16	Albert B. Chandler Medical Center, University of Kentucky	Lexington	Kentucky	United States	40536-0084
17	Johns Hopkins Oncology Center	Baltimore	Maryland	United States	21287
18	Medicine Branch	Bethesda	Maryland	United States	20892
19	Radiation Oncology Branch	Bethesda	Maryland	United States	20892
20	University of Massachusetts Memorial Medical Center	Worcester	Massachusetts	United States	01655
21	CCOP - Ann Arbor Regional	Ann Arbor	Michigan	United States	48106
22	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan	United States	48201
23	University of Minnesota Cancer Center	Minneapolis	Minnesota	United States	55455
24	University of Mississippi Medical Center	Jackson	Mississippi	United States	39216-4505
25	Washington University School of Medicine	Saint Louis	Missouri	United States	63110
26	CCOP - Southern Nevada Cancer Research Foundation	Las Vegas	Nevada	United States	89106
27	Cooper Hospital/University Medical Center	Camden	New Jersey	United States	08103
28	Cancer Center of Albany Medical Center	Albany	New York	United States	12208
29	State University of New York Health Science Center at Brooklyn	Brooklyn	New York	United States	11203
30	North Shore University Hospital	Manhasset	New York	United States	11030
31	Memorial Sloan-Kettering Cancer Center	New York	New York	United States	10021
32	University of Rochester Cancer Center	Rochester	New York	United States	14642
33	State University of New York Health Sciences Center - Stony Brook	Stony Brook	New York	United States	11790-9832
34	Lineberger Comprehensive Cancer Center, UNC	Chapel Hill	North Carolina	United States	27599-7295
35	Duke Comprehensive Cancer Center	Durham	North Carolina	United States	27710
36	Comprehensive Cancer Center of Wake Forest University Baptist Medical Center	Winston-Salem	North Carolina	United States	27157-1082
37	Barrett Cancer Center, The University Hospital	Cincinnati	Ohio	United States	45219
38	Ireland Cancer Center	Cleveland	Ohio	United States	44106-5065
39	Cleveland Clinic Cancer Center	Cleveland	Ohio	United States	44195
40	Arthur G. James Cancer Hospital - Ohio State University	Columbus	Ohio	United States	43210
41	University of Oklahoma College of Medicine	Oklahoma City	Oklahoma	United States	73190
42	Abington Memorial Hospital	Abington	Pennsylvania	United States	19001
43	Milton S. Hershey Medical Center	Hershey	Pennsylvania	United States	17033
44	University of Pennsylvania Cancer Center	Philadelphia	Pennsylvania	United States	19104
45	Kimmel Cancer Center of Thomas Jefferson University - Philadelphia	Philadelphia	Pennsylvania	United States	19107
46	Pennsylvania Hospital	Philadelphia	Pennsylvania	United States	19107
47	Fox Chase Cancer Center	Philadelphia	Pennsylvania	United States	19111
48	Medical University of South Carolina	Charleston	South Carolina	United States	29425-0721
49	CCOP - Upstate Carolina	Spartanburg	South Carolina	United States	29303
50	Simmons Cancer Center - Dallas	Dallas	Texas	United States	75235-9154
51	University of Texas - MD Anderson Cancer Center	Houston	Texas	United States	77030
52	Cancer Center, University of Virginia HSC	Charlottesville	Virginia	United States	22908
53	University of Washington Medical Center	Seattle	Washington	United States	98195-6043
54	Tacoma General Hospital	Tacoma	Washington	United States	98405