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.

Condition	Treatment or Intervention	Phase
stage IV uterine sarcoma recurrent uterine sarcoma uterine leiomyosarcoma	Drug: cisplatin  Drug: dacarbazine  Drug: doxorubicin  Drug: mitomycin  Drug: sargramostim  Procedure: biological response modifier therapy  Procedure: chemotherapy  Procedure: colony-stimulating factor therapy  Procedure: cytokine therapy  Procedure: non-specific immune-modulator therapy	Phase II

Further Study 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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

California
      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-1781,  United States
Colorado
      University of Colorado Cancer Center, Denver,  Colorado,  80010,  United States
District of Columbia
      Walter Reed Army Medical Center, Washington,  District of Columbia,  20307-5001,  United States
Illinois
      Rush-Presbyterian-St. Luke's Medical Center, Chicago,  Illinois,  60612-3864,  United States
Iowa
      Holden Comprehensive Cancer Center, Iowa City,  Iowa,  52242-1009,  United States
Maryland
      Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support, Bethesda,  Maryland,  20892-1182,  United States
Massachusetts
      Tuft-New England Medical Center, Boston,  Massachusetts,  02111,  United States
Minnesota
      Mayo Clinic Cancer Center, Rochester,  Minnesota,  55905-0001,  United States
Missouri
      Washington University School of Medicine, Saint Louis,  Missouri,  63110,  United States
New Jersey
      Cooper University Hospital, Camden,  New Jersey,  08103-1489,  United States
New York
      State University of New York Health Sciences Center - Stony Brook, Stony Brook,  New York,  11794-8091,  United States
North Carolina
      Comprehensive Cancer Center at Wake Forest University, Winston Salem,  North Carolina,  27157-1065,  United States
      Duke Comprehensive Cancer Center, Durham,  North Carolina,  27710,  United States
      Lineberger Comprehensive Cancer Center, UNC, Chapel Hill,  North Carolina,  27599-7295,  United States
Ohio
      Barrett Cancer Center, Cincinnati,  Ohio,  45267-0526,  United States
Oklahoma
      University of Oklahoma College of Medicine, Oklahoma City,  Oklahoma,  73190,  United States
Pennsylvania
      Abington Memorial Hospital, Abington,  Pennsylvania,  19001-3788,  United States
      University of Pennsylvania Cancer Center, Philadelphia,  Pennsylvania,  19104-4283,  United States
Texas
      University of Texas Medical Branch, Galveston,  Texas,  77555-0587,  United States
Washington
      Tacoma General Hospital, Tacoma,  Washington,  98405,  United States
Norway
      Norwegian Radium Hospital, Oslo,  N-0310,  Norway

Study chairs or principal investigators

Harry J. Long, MD,  Study Chair,  Mayo Clinic - Rochester   

Study ID Numbers:  CDR0000069308; GOG-0087K
Record last reviewed:  June 2003
Last Updated:  October 13, 2004
Record first received:  April 9, 2002
ClinicalTrials.gov Identifier:  NCT00033644
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08