combination chemotherapy plus sargramostim in treating patients with cancer of the uterus

Conditions: Sarcoma

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.

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.

Eligibility criteria:
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

Keywords: stage iv uterine sarcoma recurrent uterine sarcoma uterine leiomyosarcoma