Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Bethesda, Maryland 20892


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00033644


Primary Contact:

Study Chair
Harry J. Long, MD
Mayo Clinic


Backup Contact:

N/A


Location Contact:

Bethesda, Maryland 20892
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.