NCT00006044已完成1 期
A Phase I Trial of Testosterone in Patients With Progressive Androgen-Independent Prostate Cancer
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 1
研究概览
简要总结
RATIONALE: High doses of testosterone may be effective in killing prostate cancer cells that no longer respond to hormone therapy.
PURPOSE: Phase I trial to study the effectiveness of testosterone in treating patients who have progressive prostate cancer that no longer responds to hormone therapy.
详细描述
OBJECTIVES:
- Determine the safety and maximum tolerated dose of exogenously administered testosterone in patients with progressive androgen-independent prostate cancer who have been in castrate state either surgically or pharmacologically for a minimum of 1 year.
- Assess the changes in expression of androgen receptor and other receptors in human biopsy specimens or circulating tumor cells before and after this treatment in this patient population.
OUTLINE: This is a dose-escalation study.
Patients receive testosterone via an enhanced absorption transdermal system continuously for 28 days. The transdermal patches are changed daily.
Cohorts of 3-6 patients receive a fixed daily dose of testosterone with escalating duration of exposure until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicities.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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 confirmed androgen independent metastatic prostate cancer
- •Progressive disease manifested by either:
- •New osseous lesions by bone scan or a greater than 25% increase in bidimensionally measurable soft tissue disease or the appearance of new sites of disease by MRI or CT scan OR
- •Minimum of 3 rising PSA values from baseline that are obtained 1 week or more apart, or 2 rising PSA values more than 1 month apart, where the percentage increase over the range of values is at least 25%
- •Castrate state by orchiectomy or gonadotropin-releasing hormone analogues for minimum of 1 year
- •Testosterone no greater than 30 ng/mL
- •Measurable disease
- •Metastatic disease by bone scan, MRI, or CT scan
- •Rising PSA values
- •If receiving antiandrogen therapy, must have shown progressive disease off treatment
- •No active CNS or epidural tumor
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Karnofsky 60-100%
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •WBC at least 3,500/mm^3
- •Platelet count greater than 100,000/mm^3
- •Bilirubin less than 2.0 mg/dL
- •SGOT less than 3 times upper limit of normal
- •PTT less than 14 seconds
- •Creatinine less than 2.0 mg/dL OR
- •Creatinine clearance greater than 60 mL/min
- •Cardiovascular:
- •No New York Heart Association class III or IV cardiac disease
- •No severe debilitating pulmonary disease
- •No infection requiring IV antibiotics
- •No other severe medical problems that would increase risk for toxicity
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Recovered from prior biologic therapy
- •No concurrent immunotherapy
- •Chemotherapy:
- •Recovered from prior chemotherapy
- •No concurrent chemotherapy
- •Endocrine therapy:
- •See Disease Characteristics
- •If no prior orchiectomy, must continue on gonadotropin-releasing hormone analogs to maintain castrate levels of testosterone
- •No concurrent finasteride
- •No other concurrent hormonal therapy
- •Radiotherapy:
- •Recovered from prior radiotherapy
- •No concurrent radiotherapy to an indicator lesion
- •See Disease Characteristics
- •Recovered from prior surgery
- •No concurrent surgery on only measurable lesion
- •At least 4 weeks since other prior investigational anticancer drugs and recovered
- 另有 1 项未显示
排除标准
- 未提供
研究者
研究点 (1)
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