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Home > "C" Clinical Trials Conditions > Combination Chemotherapy Plus Sargramostim in Treating Patients With Cancer of the Uterus  Combination Chemotherapy Plus Sargramostim in Treating Patients With Cancer of the Uterus
Combination Chemotherapy Plus Sargramostim in Treating Patients With Cancer of the Uterus
For Condition: recurrent uterine sarcoma,stage 4 uterine sarcoma,uterine leiomyosarcoma
Status: Suspended
Sponsor(s): Gynecologic Oncology Group , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HarryLong, Study Chair, Mayo Clinic - Rochester
University of Texas Medical Branch
Galveston, Texas, 77555-0587
United States
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, 60612-3864
United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5001
United States
Tuft-New England Medical Center
Boston, Massachusetts, 02111
United States
University of Colorado Cancer Center
Denver, Colorado, 80010
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma, 73190
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
Tacoma General Hospital
Tacoma, Washington, 98405
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905-0001
United States
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1065
United States
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, 20892-1182
United States
Norwegian Radium Hospital
Oslo, , N-0310
Norway
Barrett Cancer Center
Cincinnati, Ohio, 45267-0526
United States
Washington University School of Medicine
St. Louis, Missouri, 63110
United States
Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242-1009
United States
Cooper University Hospital
Camden, New Jersey, 08103-1489
United States
State University of New York Health Sciences Center - Stony Brook
Stony Brook, New York, 11794-8091
United States
Abington Memorial Hospital
Abington, Pennsylvania, 19001-3788
United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104-4283
United States
Additional Information:
Study ID Numbers: CDR0000069308; GOG-0087K
Study Start Date:
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00033644
Other Stage 4 Uterine Sarcoma Studies:
1. Combination Chemotherapy in Treating Patients With Endometrial Cancer, Fallopian Tube Cancer, or Sarcoma of the Female Reproductive Tract
2. Radiation Therapy Compared With Combination Chemotherapy in Treating Patients With Cancer of the Uterus
3. Combination Chemotherapy Plus Sargramostim in Treating Patients With Cancer of the Uterus
4. Ifosfamide With or Without Paclitaxel in Treating Patients With Advanced, Refractory, or Recurrent Cancer of the Uterus
5. Chemotherapy in Treating Patients With Sarcoma of the Uterus
Related Studies:
Other stage 4 uterine sarcoma Clinical Trials
Other North Carolina Clinical Trials
Other Winston Salem Clinical Trials
Combination Chemotherapy Plus Sargramostim in Treating Patients With Cancer of the Uterus
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