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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Sarcoma

Intervention / Treatment
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* Biological: sargramostim
* Drug: cisplatin
* Drug: dacarbazine
* Drug: doxorubicin hydrochloride
* Drug: mitomycin C


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: sargramostim|nan|
|Drug: cisplatin|nan|
|Drug: dacarbazine|nan|
|Drug: doxorubicin hydrochloride|nan|
|Drug: mitomycin C|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV uterine sarcoma, recurrent uterine sarcoma, uterine leiomyosarcoma