Combination Chemotherapy Plus Sargramostim in Treating Patients With Cancer of the Uterus

Sponsor

Gynecologic Oncology Group (Other)

Overall Status

Terminated

CT.gov ID

NCT00033644

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. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus sargramostim in treating patients who have advanced, persistent, or recurrent cancer of the uterus.

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

Detailed Description

OBJECTIVES:

Determine the antitumor activity of dacarbazine, mitomycin, doxorubicin, and cisplatin plus sargramostim (GM-CSF) in patients with advanced, persistent, or recurrent leiomyosarcoma of the uterus.
Determine the nature and degree of toxicity of this regimen in these patients.

OUTLINE: Patients receive dacarbazine IV over 2 hours, followed by mitomycin IV over 2-5 minutes, doxorubicin IV over 2-5 minutes, and cisplatin IV over 2 hours on day 1. Patients also receive sargramostim (GM-CSF) subcutaneously (SC) once every 12 hours on days -6 to -3 before the first chemotherapy course and then on days 2-15 and 23-26 of all chemotherapy courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease receive a maximum of 4 courses. Patients achieving complete or partial response receive a maximum of 6 courses.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 12-43 patients will be accrued for this study within 12-28 months.

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

A Phase II Evaluation of DMAP Plus GM-CSF in the Treatment of Advanced, Persistent, or Recurrent Leiomyosarcoma of the Uterus

Study Start Date :

Mar 1, 2002

Actual Primary Completion Date :

Oct 1, 2005

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

Histologically confirmed primary leiomyosarcoma (LMS) of the uterus
Advanced, persistent, or recurrent disease that is refractory to curative therapy or established treatments
At least 1 unidimensionally measurable target lesion
At least 20 mm by conventional techniques (e.g., palpation, plain x-ray, CT scan, or MRI) OR
At least 10 mm by spiral CT scan
Tumors within a previously irradiated field are designated as non-target lesions
Ineligible for a higher priority Gynecologic Oncology Group protocol (if one exists), including any active phase III protocol for the same population

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

GOG 0-2

Life expectancy:

Not specified

Hematopoietic:

Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3

Hepatic:

Bilirubin no greater than 1.5 times upper limit of normal (ULN)
SGOT no greater than 2.5 times ULN
Alkaline phosphatase no greater than 2.5 times ULN

Renal:

Creatinine no greater than 1.5 times ULN

Other:

No active infection requiring antibiotics
No grade 2 or greater sensory or motor neuropathy
No other invasive malignancy within the past 5 years except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

No prior cytotoxic chemotherapy for LMS of the uterus

Endocrine therapy:

At least 1 week since prior hormonal therapy for LMS of the uterus
Concurrent hormone replacement therapy allowed

Radiotherapy:

See Disease Characteristics
Recovered from prior recent radiotherapy

Surgery:

Recovered from prior recent surgery

Other:

Recovered from other prior recent therapy
No prior cancer treatment that would preclude study therapy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California	United States	90095-1781
2	University of Colorado Cancer Center	Denver	Colorado	United States	80010
3	Walter Reed Army Medical Center	Washington	District of Columbia	United States	20307-5001
4	Rush-Presbyterian-St. Luke's Medical Center	Chicago	Illinois	United States	60612-3864
5	Holden Comprehensive Cancer Center	Iowa City	Iowa	United States	52242-1009
6	Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support	Bethesda	Maryland	United States	20892-1182
7	Tuft-New England Medical Center	Boston	Massachusetts	United States	02111
8	Mayo Clinic Cancer Center	Rochester	Minnesota	United States	55905-0001
9	Washington University School of Medicine	Saint Louis	Missouri	United States	63110
10	Cooper University Hospital	Camden	New Jersey	United States	08103-1489
11	State University of New York Health Sciences Center - Stony Brook	Stony Brook	New York	United States	11794-8091
12	Lineberger Comprehensive Cancer Center, UNC	Chapel Hill	North Carolina	United States	27599-7295
13	Duke Comprehensive Cancer Center	Durham	North Carolina	United States	27710
14	Comprehensive Cancer Center at Wake Forest University	Winston-Salem	North Carolina	United States	27157-1065
15	Barrett Cancer Center	Cincinnati	Ohio	United States	45267-0526
16	University of Oklahoma College of Medicine	Oklahoma City	Oklahoma	United States	73190
17	Abington Memorial Hospital	Abington	Pennsylvania	United States	19001-3788
18	University of Pennsylvania Cancer Center	Philadelphia	Pennsylvania	United States	19104-4283
19	University of Texas Medical Branch	Galveston	Texas	United States	77555-0587
20	Tacoma General Hospital	Tacoma	Washington	United States	98405
21	Norwegian Radium Hospital	Oslo		Norway	N-0310