NCT00017134终止不适用
An Exploratory Evaluation of Fenretinide (4-HPR) as a Chemopreventive Agent for Ovarian Carcinoma
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 71
- 试验地点
- 35
研究概览
简要总结
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. It is not yet known whether fenretinide given before surgery is more effective in preventing ovarian cancer than surgery alone.
PURPOSE: Randomized clinical trial to compare the effectiveness of fenretinide followed by surgery with that of surgery alone in preventing ovarian cancer in patients who are at increased risk.
详细描述
OBJECTIVES:
- Compare the frequency of histopathology markers or precursor lesions of the ovaries, including surface papillomatosis, invaginations, pseudostratification, and inclusion cysts, removed from patients at increased risk for ovarian cancer between those receiving fenretinide vs those undergoing immediate oophorectomy.
- Determine the relative abundance of markers of cell proliferation and apoptosis in cancer-prone ovaries of patients treated with fenretinide.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 arms.
- Arm I: Patients undergo prophylactic oophorectomy.
- Arm II: Patients receive oral fenretinide once daily for 27 days every 30 days for 6-8 weeks. Treatment continues in the absence of unacceptable toxicity or diagnosis of malignancy. After completion of fenretinide, patients undergo prophylactic oophorectomy.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Prevention
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Increased risk for ovarian cancer secondary to 1 of the following:
- •Evidence of a BRCA1 or BRCA2 genetic mutation
- •Family history of 1 or more first-degree relatives diagnosed with ovarian cancer prior to 50 years of age
- •Family history of 1 first-degree relative with ovarian cancer (any age) AND 1 or more first- or second-degree relatives diagnosed with breast or ovarian cancer
- •Personal history of breast cancer (at any age) AND 1 or more first- or second-degree relative diagnosed with breast or ovarian cancer at any age
- •Meets any 1 of the following criteria:
- •Ashkenazi Jewish ethnicity with 1 first-degree or 2 second-degree relatives with breast* and/or ovarian cancer
- •Ashkenazi Jewish ethnicity with diagnosed breast* cancer in patient
- •Greater than 20% probability of carrying BRCA1/2 mutation with a family history of breast and ovarian cancer NOTE: * Where breast cancer is required to meet this criteria, diagnosis must occur prior to menopause or at ≤ 50 years old if age at menopause is unknown
- •Planned prophylactic oophorectomy
- •Normal pelvic exam within the past 6 weeks
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •At least 12 months
- •Hematopoietic:
- •WBC at least 4,000/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 1.5 mg/dL
- •SGOT no greater than 2 times upper limit of normal (ULN)
- •Creatinine no greater than 1.5 mg/dL OR
- •Creatinine clearance at least 60 mL/min
- •Triglyceride less than 2 times ULN (fasting)
- •Cardiovascular:
- •No myocardial infarction within the past 3 months
- •No active angina
- •No unstable heart rhythms
- •No clinically evident congestive heart failure
- •No uncontrolled medical illness that would preclude study participation
- •No uncontrolled diabetes
- •No uncontrolled psychiatric illness
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective barrier contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •At least 3 months since prior chemotherapy
- •Endocrine therapy:
- •At least 3 months since prior hormonal therapy
- •At least 8 weeks since prior hormone replacement therapy
- •At least 8 weeks since prior oral, injectable, or implantable contraceptives
- •No concurrent hormonal therapy, including hormone replacement therapy
- •Radiotherapy:
- •At least 3 months since prior radiotherapy
- •No prior radiotherapy to pelvis for malignancy
- •See Disease Characteristics
- 另有 5 项未显示
排除标准
- 未提供
研究者
研究点 (35)
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