NCT00238225已完成1 期
A Phase I Study of Oral Calcitriol in Combination With Ketoconazole in Refractory Advanced Malignancies
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Maximum tolerated dose (MTD) of calcitriol
研究概览
简要总结
RATIONALE: Calcitriol may cause solid tumor cells to look more like normal cells, and to grow and spread more slowly. Ketoconazole and dexamethasone may help calcitriol work better by making tumor cells more sensitive to the drug. Giving calcitriol together with ketoconazole and dexamethasone may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of calcitriol when given together with ketoconazole and dexamethasone in treating patients with metastatic or unresectable solid tumors.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of calcitriol when administered with ketoconazole and dexamethasone in patients with metastatic or unresectable solid tumors.
Secondary
- Determine the tolerability and toxic effects of this regimen in these patients.
- Determine tumor response in patients treated with this regimen.
- Determine the pharmacokinetics of calcitriol and dexamethasone with or without ketoconazole in these patients.
- Determine the pharmacodynamics of this regimen, in terms of CYP24 expression and activity and vitamin D receptor expression in peripheral blood mononuclear cells, in these patients.
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
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed solid tumor
- •Metastatic or unresectable disease
- •Standard curative or reliable palliative therapy is no longer effective OR does not exist
- •Brain metastases allowed provided they have been treated with surgery or radiotherapy AND are stable
- •PATIENT CHARACTERISTICS:
- •Performance status
- •ECOG 0-2 OR
- •Karnofsky 60-100%
- •Life expectancy
- •More than 3 months
- •Hematopoietic
- •WBC ≥ 3,000/mm^3
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Hemoglobin ≥ 8 g/dL
- •Platelet count ≥ 75,000/mm^3
- •AST/ALT ≤ 2.5 times upper limit of normal
- •Bilirubin normal
- •No unstable or uncompensated hepatic disease
- •Creatinine ≤ 2 mg/dL
- •No unstable or uncompensated renal disease
- •No history of kidney, urethral, or bladder stones within the past 5 years
- •Cardiovascular
- •Ejection fraction ≥ 30%
- •No symptomatic congestive heart failure
- •No significant arrhythmias
- •No myocardial infarction within the past 3 months
- •No unstable angina pectoris
- •No unstable or uncompensated cardiac disease
- •No other significant heart disease
- •No unstable or uncompensated respiratory disease
- •Immunologic
- •No known severe hypersensitivity to ketoconazole or calcitriol or any of the excipients of these products
- •No history of allergic reaction attributed to compounds of similar chemical or biological composition to the study drugs
- •No ongoing or active infection
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception prior to, during, and for 3 months after completion of study treatment
- •Able to receive oral medication
- •No sperm donation during and for ≥ 3 months after completion of study treatment
- •No evidence of significant clinical disorder or laboratory finding that would preclude study participation
- •No other severe or uncontrolled systemic disease
- •No psychiatric illness or social situation that would preclude study compliance
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No concurrent prophylactic growth factors, including filgrastim (G-CSF) or sargramostim (GM-CSF)
- •Chemotherapy
- •At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
- •Any number of prior chemotherapy regimens allowed
- •Endocrine therapy
- 另有 21 项未显示
排除标准
- 未提供
结局指标
主要结局
Maximum tolerated dose (MTD) of calcitriol
次要结局
- Pharmacokinetics of calcitriol and dexamethasone with or without ketoconazole
研究者
研究点 (2)
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