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

Phase 2TerminatedNCT00033644

Gynecologic Oncology Group

Overview

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.

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 Type

INTERVENTIONAL

Purpose

TREATMENT

Conditions

Sarcoma

Interventions

sargramostimBIOLOGICAL

cisplatinDRUG

dacarbazineDRUG

doxorubicin hydrochlorideDRUG

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (21)

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, United States

Data from ClinicalTrials.gov

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