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.
調査の概要
詳細な説明
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.
研究の種類
段階
- フェーズ2
連絡先と場所
研究場所
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California
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Los Angeles、California、アメリカ、90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Colorado
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Denver、Colorado、アメリカ、80010
- University of Colorado Cancer Center
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District of Columbia
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Washington、District of Columbia、アメリカ、20307-5001
- Walter Reed Army Medical Center
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Illinois
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Chicago、Illinois、アメリカ、60612-3864
- Rush-Presbyterian-St. Luke's Medical Center
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Iowa
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Iowa City、Iowa、アメリカ、52242-1009
- Holden Comprehensive Cancer Center
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Maryland
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Bethesda、Maryland、アメリカ、20892-1182
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
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Massachusetts
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Boston、Massachusetts、アメリカ、02111
- Tuft-New England Medical Center
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Minnesota
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Rochester、Minnesota、アメリカ、55905-0001
- Mayo Clinic Cancer Center
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Missouri
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Saint Louis、Missouri、アメリカ、63110
- Washington University School of Medicine
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New Jersey
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Camden、New Jersey、アメリカ、08103-1489
- Cooper University Hospital
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New York
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Stony Brook、New York、アメリカ、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、アメリカ、27599-7295
- Lineberger Comprehensive Cancer Center, UNC
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Durham、North Carolina、アメリカ、27710
- Duke Comprehensive Cancer Center
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Winston-Salem、North Carolina、アメリカ、27157-1065
- Comprehensive Cancer Center at Wake Forest University
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Ohio
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Cincinnati、Ohio、アメリカ、45267-0526
- Barrett Cancer Center
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Oklahoma
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Oklahoma City、Oklahoma、アメリカ、73190
- University of Oklahoma College of Medicine
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Pennsylvania
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Abington、Pennsylvania、アメリカ、19001-3788
- Abington Memorial Hospital
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Philadelphia、Pennsylvania、アメリカ、19104-4283
- University of Pennsylvania Cancer Center
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Texas
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Galveston、Texas、アメリカ、77555-0587
- University of Texas Medical Branch
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Washington
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Tacoma、Washington、アメリカ、98405
- Tacoma General Hospital
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Oslo、ノルウェー、N-0310
- Norwegian Radium Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
協力者と研究者
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- CDR0000069308
- GOG-0087K
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