Combination Chemotherapy Plus Sargramostim in Treating Patients With Cancer of the Uterus
A Phase II Evaluation of DMAP Plus GM-CSF in the Treatment of Advanced, Persistent, or Recurrent Leiomyosarcoma of the Uterus
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.
연구 개요
상세 설명
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.
연구 유형
단계
- 2 단계
연락처 및 위치
연구 장소
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Oslo, 노르웨이, N-0310
- Norwegian Radium Hospital
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California
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Los Angeles, California, 미국, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Colorado
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Denver, Colorado, 미국, 80010
- University of Colorado Cancer Center
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District of Columbia
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Washington, District of Columbia, 미국, 20307-5001
- Walter Reed Army Medical Center
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Illinois
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Chicago, Illinois, 미국, 60612-3864
- Rush-Presbyterian-St. Luke's Medical Center
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Iowa
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Iowa City, Iowa, 미국, 52242-1009
- Holden Comprehensive Cancer Center
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Maryland
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Bethesda, Maryland, 미국, 20892-1182
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
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Massachusetts
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Boston, Massachusetts, 미국, 02111
- Tuft-New England Medical Center
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Minnesota
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Rochester, Minnesota, 미국, 55905-0001
- Mayo Clinic Cancer Center
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Missouri
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Saint Louis, Missouri, 미국, 63110
- Washington University School of Medicine
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New Jersey
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Camden, New Jersey, 미국, 08103-1489
- Cooper University Hospital
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New York
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Stony Brook, New York, 미국, 11794-8091
- State University of New York Health Sciences Center - Stony Brook
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North Carolina
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Chapel Hill, North Carolina, 미국, 27599-7295
- Lineberger Comprehensive Cancer Center, UNC
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Durham, North Carolina, 미국, 27710
- Duke Comprehensive Cancer Center
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Winston-Salem, North Carolina, 미국, 27157-1065
- Comprehensive Cancer Center at Wake Forest University
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Ohio
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Cincinnati, Ohio, 미국, 45267-0526
- Barrett Cancer Center
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Oklahoma
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Oklahoma City, Oklahoma, 미국, 73190
- University of Oklahoma College of Medicine
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Pennsylvania
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Abington, Pennsylvania, 미국, 19001-3788
- Abington Memorial Hospital
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Philadelphia, Pennsylvania, 미국, 19104-4283
- University of Pennsylvania Cancer Center
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Texas
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Galveston, Texas, 미국, 77555-0587
- University of Texas Medical Branch
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Washington
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Tacoma, Washington, 미국, 98405
- Tacoma General Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
공동 작업자 및 조사자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- CDR0000069308
- GOG-0087K
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