NCT00077402已完成2 期
A Phase 2 Study Of Fenretinide In Patients With Hormone Refractory Prostate Cancer
Cancer Therapeutics Research Group11 个研究点 分布在 3 个国家目标入组 50 人开始时间: 2003年11月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 11
- 主要终点
- Response rate as measured by RECIST at ≥ 9 weeks
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as fenretinide, work in different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well fenretinide works in treating patients with advanced or metastatic hormone-refractory prostate cancer.
详细描述
OBJECTIVES:
Primary
- Determine the activity of fenretinide, in terms of the prostate-specific antigen (PSA) response rate, in patients with advanced or metastatic hormone-refractory prostate cancer.
Secondary
- Determine the objective response rate in patients with identifiable soft tissue disease treated with this drug.
- Determine the duration of PSA response in patients treated with this drug.
- Determine PSA progression-free survival of patients treated with this drug.
- Determine overall survival of patients treated with this drug.
- Determine the toxicity of this drug in these patients.
- Determine self-rated symptoms, functions, attitudes to oral therapy, and quality of life of patients treated with this drug.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed adenocarcinoma of the prostate
- •Measurable or non-measurable disease
- •Metastatic disease allowed
- •Castrate levels of serum testosterone (either after orchiectomy or maintained on a luteinizing hormone-releasing hormone agonist or antagonist)
- •Prostate-specific antigen (PSA) greater than 10 ng/mL at baseline and rising, with 2 consecutive increases measured at least 1 week apart*
- •No known brain metastases NOTE: *If the third PSA value has not risen above the second PSA value, a fourth measurement must be obtained that is higher than the second value
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Life expectancy
- •More than 12 weeks
- •Hematopoietic
- •Absolute neutrophil count greater than 1,500/mm^3
- •WBC greater than 3,000/mm^3
- •Platelet count greater than 100,000/mm^3
- •AST and ALT no greater than 2.5 times upper limit of normal
- •Bilirubin normal
- •Creatinine normal OR
- •Creatinine clearance greater than 60 mL/min
- •Cardiovascular
- •No symptomatic congestive heart failure
- •No unstable angina pectoris
- •No cardiac arrhythmia
- •Able to tolerate oral medication
- •Fertile patients must use effective contraception
- •No prior allergic reaction to compounds of similar chemical or biological composition to fenretinide
- •No other concurrent uncontrolled illness
- •No ongoing or active infection
- •No psychiatric illness or social situation that would preclude study compliance
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •No prior cytotoxic chemotherapy
- •Endocrine therapy
- •See Disease Characteristics
- •At least 6 weeks since prior antiandrogen therapy with any of the following:
- •Cyproterone
- •Flutamide
- •Bicalutamide
- •Nilutamide
- •Concurrent corticosteroids allowed provided therapy was initiated before study entry
- •Radiotherapy
- •At least 4 weeks since prior radiotherapy and recovered
- •No concurrent radiotherapy, including for pain
- •No concurrent radioisotopes (e.g., strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium)
- •More than 4 weeks since prior investigational agents
- •No concurrent antioxidants (e.g., ascorbic acid or vitamin E), vitamin A, or beta carotene supplements
- •No concurrent combination antiretroviral therapy for HIV-positive patients
- •No other concurrent investigational or commercial anticancer agents or therapies
排除标准
- 未提供
结局指标
主要结局
Response rate as measured by RECIST at ≥ 9 weeks
次要结局
- Toxicity as measured by NCI CTC
研究者
研究点 (11)
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