Effect of Oral Ketoconazole on the Pharmacokinetics of Oral Dexamethasone and Oral Hydrocortisone in Patients With Androgen Independent Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Pharmacokinetics of oral dexamethasone with and without oral ketoconazole
研究概览
简要总结
RATIONALE: Studying samples of blood in the laboratory from patients with cancer receiving ketoconazole together with dexamethasone and hydrocortisone may help doctors learn more about how these drugs are used by the body.
PURPOSE: This randomized clinical trial is studying how ketoconazole, dexamethasone, and hydrocortisone act in the body of patients with prostate cancer that did not respond to androgen-deprivation therapy.
详细描述
OBJECTIVES:
- To evaluate the pharmacokinetics of oral dexamethasone with and without oral ketoconazole in patients with androgen-independent prostate cancer.
- To compare the pharmacokinetics of oral hydrocortisone with and without oral ketoconazole in these patients.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral dexamethasone twice daily on days 1-14, oral ketoconazole 3 times daily on days 2-14 and 30-42, and oral hydrocortisone twice daily on days 29-42.
- Arm II: Patients receive oral hydrocortisone twice daily on days 1-14, oral ketoconazole 3 times daily on days 2-14 and 30-42, and oral dexamethasone twice daily on days 29-42.
In both arms, patients may receive ketoconazole and hydrocortisone as standard salvage therapy off study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Confirmed diagnosis of prostate cancer
- •Must have failed standard androgen-deprivation therapy
- •Evidence of rising PSA
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •Creatinine ≤ 2.0 mg/dL
- •AST and ALT < 4 times upper limit of normal
- •Bilirubin < 2.0 mg/dL
- •No active congestive heart failure
- •No allergy to ketoconazole, dexamethasone, hydrocortisone, or to one of the components of dexamethasone, hydrocortisone, or ketoconazole
- •No active infection
- •No uncontrolled glaucoma
- •No active peptic ulcer disease
- •No uncontrolled diabetes mellitus
- •Fertile patients must use effective contraception during and for 3 months after completion of study therapy
- •PRIOR CONCURRENT THERAPY:
- •More than 2 weeks since prior and no concurrent drugs known to interact with study treatment
排除标准
- 未提供
结局指标
主要结局
Pharmacokinetics of oral dexamethasone with and without oral ketoconazole
Pharmacokinetics of oral hydrocortisone with and without oral ketoconazole
次要结局
未报告次要终点