NCT00098800已完成不适用
A Multicenter Randomized Double-Blinded Trial for Chemoprevention of Ovarian Cancer: Modulation of Biomarkers and Spectral Properties Using Contrast Enhanced Ultrasound in High-Risk Women Using Fenretinide (4-HPR)
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of fenretinide may prevent ovarian cancer.
PURPOSE: This randomized clinical trial is studying how well fenretinide works in preventing ovarian cancer in participants who are at high risk of developing ovarian cancer and planning to undergo surgery to remove the ovaries.
详细描述
OBJECTIVES:
Primary
- Compare the induction of apoptosis (as determined by TUNEL) in the ovarian epithelial and stromal cells of participants at high risk for ovarian cancer treated with fenretinide vs placebo.
Secondary
- Compare modulation of several intermediate markers (TGFβ, BAX, Ki-67, ER, PR, RARβ, TGFβRI, TGFβRII, p21, p53, FAS, and FASL) in participants treated with these regimens.
- Compare early microvascular changes, using contrast-enhanced ultrasound, in participants treated with these drugs.
- Determine whether the use of contrast agents could indicate changes in ovarian size and architecture that may be assessed as potential surrogates for preventive effect in these participants.
- Determine the feasibility of future chemoprevention trials for ovarian cancer.
- Determine the toxicity of fenretinide in these participants.
- Compare the microvascularity index and ovarian volume of participants treated with these drugs.
- Correlate areas of increased microvascularity and other abnormalities with pathology findings obtained at oophorectomy in participants treated with these drugs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •At high risk for developing ovarian cancer, meeting 1 of the following criteria:
- •Family history of ovarian cancer, defined as ≥ 1 first-degree relative diagnosed with ovarian cancer before 50 years of age
- •Family history of ovarian cancer, defined as ≥ 1 first-degree relative diagnosed with ovarian cancer at any age AND ≥ 1 first- or second-degree relative diagnosed with breast or ovarian cancer at any age
- •Positive BRCA1/BRCA2 test
- •Planning to undergo prophylactic bilateral oophorectomy
- •PATIENT CHARACTERISTICS:
- •30 and over
- •Performance status
- •Zubrod 0-1
- •Life expectancy
- •At least 12 months
- •Hematopoietic
- •Not specified
- •Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •SGOT ≤ 1.5 times ULN
- •Alkaline phosphatase ≤ 1.5 times ULN
- •No history of liver disease*
- •No cholestatic jaundice
- •No hepatic adenomas NOTE: *For patients undergoing contrast enhanced ultrasound
- •BUN normal
- •Creatinine normal
- •Cardiovascular
- •No history of a congenital heart defect creating a bi-directional or right-to-left shunt*
- •No history of congestive heart failure*
- •No thrombophlebitis
- •No thromboembolic disease
- •No cerebral vascular disease
- •No coronary artery disease NOTE: *For patients undergoing contrast enhanced ultrasound
- •No history of pulmonary hypertension*
- •No history of pulmonary emboli*
- •No history of severe emphysema* NOTE: *For patients undergoing contrast enhanced ultrasound
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective barrier contraception
- •Thyroid stimulating hormone normal
- •T4 normal
- •Triglycerides ≤ 1.5 times ULN
- •No malignancy within the past 5 years except breast cancer or basal cell or squamous cell skin cancer
- •No evidence of recurrent disease
- •No known or suspected hypersensitivity to blood, blood products, or albumin
- •No undiagnosed genital bleeding
- •No history of pancreatitis
- •No uncontrolled diabetes
- •No other severe underlying chronic disease
- •No concurrent alcohol use (> 3 drinks/day or equivalent)
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
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排除标准
- 未提供
研究者
研究点 (2)
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