Liposomal Doxorubicin and Etoposide in Treating Patients With Recurrent or Persistent Ovarian, Fallopian Tube, or Peritoneal Cancer
A Phase I Study of Liposomal Doxorubicin (Doxil) and Prolonged Etoposide As Second Line Therapy in Ovarian, Tubal and Peritoneal Carcinoma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy consisting of liposomal doxorubicin and etoposide in treating patients who have recurrent or persistent ovarian, fallopian tube, or peritoneal cancer.
研究概览
详细说明
OBJECTIVES: I. Determine the optimal dose of doxorubicin HCl liposomal and prolonged oral etoposide in patients with recurrent or persistent ovarian, tubal, and peritoneal carcinoma. II. Determine the nature and degree of toxicity of this therapy in these patients. III. Evaluate the response rate of patients with measurable disease.
OUTLINE: This is a dose escalation, multicenter study of etoposide and doxorubicin HCl liposome. Patients receive doxorubicin HCl liposome IV over 1 hour on day 1, followed by oral etoposide for 8-14 days beginning on day 2. For patients who achieve partial or complete response, treatment repeats every 4 weeks for 1 year in the absence of disease progression or unacceptable toxicity. For patients with stable disease, treatment repeats every 4 weeks for 6 months. In the absence of dose limiting toxicity (DLT) in the first 3 patients treated, subsequent cohorts of 3-6 patients each receive doses of etoposide for more prolonged periods. After 14 days of oral etoposide, the dose of doxorubicin HCl liposome is escalated. The maximum tolerated dose is defined as the dose preceding that at which 2 of 6 patients experience DLT. Patients are followed every 3 months for 1 year, then until death.
PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study within 1 year.
研究类型
阶段
- 阶段1
联系人和位置
学习地点
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Ontario
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Kingston、Ontario、加拿大、K7L 3N6
- NCIC-Clinical Trials Group
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Alabama
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Birmingham、Alabama、美国、35294
- University of Alabama Comprehensive Cancer Center
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Arizona
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Phoenix、Arizona、美国、85006-2726
- CCOP - Greater Phoenix
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California
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Los Angeles、California、美国、90033-0800
- USC/Norris Comprehensive Cancer Center
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Los Angeles、California、美国、90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Palo Alto、California、美国、94304
- Women's Cancer Center
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Colorado
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Denver、Colorado、美国、80262
- University of Colorado Cancer Center
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District of Columbia
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Washington、District of Columbia、美国、20307-5000
- Walter Reed Army Medical Center
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Washington、District of Columbia、美国、20007
- Vincent T. Lombardi Cancer Research Center, Georgetown University
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Florida
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Tampa、Florida、美国、33612
- H. Lee Moffitt Cancer Center and Research Institute
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Georgia
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Atlanta、Georgia、美国、30322
- Emory University Hospital - Atlanta
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Atlanta、Georgia、美国、30342-1701
- CCOP - Atlanta Regional
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Hawaii
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Honolulu、Hawaii、美国、96813
- MBCCOP - Hawaii
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Illinois
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Chicago、Illinois、美国、60612
- Rush-Presbyterian-St. Luke's Medical Center
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Chicago、Illinois、美国、60637
- University of Chicago Cancer Research Center
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Evanston、Illinois、美国、60201
- CCOP - Evanston
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Springfield、Illinois、美国、62526
- CCOP - Central Illinois
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Indiana
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Indianapolis、Indiana、美国、46202-5265
- Indiana University Cancer Center
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Iowa
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Iowa City、Iowa、美国、52242
- University of Iowa Hospitals and Clinics
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Kentucky
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Lexington、Kentucky、美国、40536-0084
- Albert B. Chandler Medical Center, University of Kentucky
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Maryland
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Baltimore、Maryland、美国、21287
- Johns Hopkins Oncology Center
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Bethesda、Maryland、美国、20892
- Radiation Oncology Branch
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Bethesda、Maryland、美国、20892
- Medicine Branch
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Massachusetts
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Worcester、Massachusetts、美国、01655
- University of Massachusetts Memorial Medical Center
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Michigan
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Ann Arbor、Michigan、美国、48106
- CCOP - Ann Arbor Regional
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Detroit、Michigan、美国、48201
- Barbara Ann Karmanos Cancer Institute
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Mississippi
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Jackson、Mississippi、美国、39216-4505
- University of Mississippi Medical Center
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Keesler AFB、Mississippi、美国、39534-2576
- Keesler Medical Center - Keesler AFB
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Missouri
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Kansas City、Missouri、美国、64131
- CCOP - Kansas City
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Saint Louis、Missouri、美国、63110
- Washington University School of Medicine
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Montana
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Billings、Montana、美国、59101
- CCOP - Montana Cancer Consortium
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Nebraska
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Omaha、Nebraska、美国、68131
- CCOP - Missouri Valley Cancer Consortium
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Nevada
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Las Vegas、Nevada、美国、89106
- CCOP - Southern Nevada Cancer Research Foundation
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New Jersey
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Camden、New Jersey、美国、08103
- Cooper Hospital/University Medical Center
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New York
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Albany、New York、美国、12208
- Cancer Center of Albany Medical Center
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Brooklyn、New York、美国、11203
- State University of New York Health Science Center at Brooklyn
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Manhasset、New York、美国、11030
- North Shore University Hospital
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New York、New York、美国、10021
- Memorial Sloan-Kettering Cancer Center
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Stony Brook、New York、美国、11790-9832
- State University of New York Health Sciences Center - Stony Brook
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North Carolina
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Chapel Hill、North Carolina、美国、27599-7295
- Lineberger Comprehensive Cancer Center, UNC
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Durham、North Carolina、美国、27710
- Duke Comprehensive Cancer Center
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Winston-Salem、North Carolina、美国、27157-1082
- Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
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Winston-Salem、North Carolina、美国、27103
- Brookview Research, Inc.
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Ohio
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Cincinnati、Ohio、美国、45219
- Barrett Cancer Center, The University Hospital
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Cleveland、Ohio、美国、44195
- Cleveland Clinic Cancer Center
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Cleveland、Ohio、美国、44106-5065
- Ireland Cancer Center
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Columbus、Ohio、美国、43210
- Arthur G. James Cancer Hospital - Ohio State University
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Oklahoma
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Oklahoma City、Oklahoma、美国、73190
- University of Oklahoma College of Medicine
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Tulsa、Oklahoma、美国、74136
- CCOP - St. Francis Hospital/Natalie Warren Bryant Cancer Center
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Oregon
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Portland、Oregon、美国、97213
- CCOP - Columbia River Program
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Pennsylvania
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Abington、Pennsylvania、美国、19001
- Abington Memorial Hospital
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Hershey、Pennsylvania、美国、17033
- Milton S. Hershey Medical Center
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Philadelphia、Pennsylvania、美国、19111
- Fox Chase Cancer Center
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Philadelphia、Pennsylvania、美国、19107
- Pennsylvania Hospital
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Philadelphia、Pennsylvania、美国、19104
- University of Pennsylvania Cancer Center
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Philadelphia、Pennsylvania、美国、19107
- Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
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South Carolina
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Charleston、South Carolina、美国、29425-0721
- Medical University of South Carolina
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Spartanburg、South Carolina、美国、29303
- CCOP - Upstate Carolina
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Tennessee
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Memphis、Tennessee、美国、38117
- CCOP - Baptist Cancer Institute
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Texas
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Dallas、Texas、美国、75235-9154
- Simmons Cancer Center - Dallas
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Houston、Texas、美国、77030
- University of Texas - MD Anderson Cancer Center
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Washington
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Seattle、Washington、美国、98195-6043
- University of Washington Medical Center
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Tacoma、Washington、美国、98405
- Tacoma General Hospital
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
描述
DISEASE CHARACTERISTICS: Histologically proven recurrent or persistent ovarian, tubal, or peritoneal carcinoma of the following cell types: Serous adenocarcinoma Mucinous adenocarcinoma Clear cell adenocarcinoma Transitional cell Endometrioid adenocarcinoma Undifferentiated carcinoma Mixed epithelial carcinoma Malignant Brenner tumor Adenocarcinoma not otherwise specified Must not be eligible for any other higher priority phase II or phase III GOG protocol
PATIENT CHARACTERISTICS: Age: Not specified Performance status: GOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Granulocyte count at least 1,500/mm3 Hepatic: Bilirubin no greater than 1.5 times normal SGOT/SGPT/GGT no greater than 2.5 times normal Alkaline phosphatase no greater than 2.5 times normal No acute hepatitis Renal: Creatinine no greater than 2.0 mg/dL Creatinine clearance greater than 50 mL/min Cardiovascular: LVEF within normal range as determined by MUGA No congestive heart failure or unstable angina No myocardial infarction within the past 6 months Prior abnormal cardiac conduction (e.g., bundle branch block, heart block) allowed if stable for at least 6 months Other: No significant infection No septicemia Body surface area at least 1 m2 Adequate intestinal function (i.e., does not require IV hydration or nutritional support) No severe gastrointestinal bleeding No other invasive malignancies within the past 5 years except nonmelanomatous skin cancer
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior biologic therapy and recovered Chemotherapy: Must have received at least 1 prior cisplatin-paclitaxel based regimen At least 3 weeks since prior chemotherapy and recovered No prior anthracycline therapy Endocrine therapy: At least 3 weeks since prior endocrine therapy and recovered Radiotherapy: No prior radiotherapy to more than 10% of bone marrow Surgery: At least 3 weeks since prior surgery and recovered
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
合作者和调查者
调查人员
- 学习椅：Peter G. Rose, MD、The Cleveland Clinic
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
依托泊甙的临床试验
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Tianjin Medical University Cancer Institute and...CSPC Ouyi Pharmaceutical Co., Ltd.尚未招聘