NCT00022295已完成1 期
Phase IB Study of Phenoxodiol Given by Constant Intravenous Infusion in Patients With Solid Neoplasms (With the Exception of Breast Cancer) Whose Tumors Are Refractory to Standard Therapy
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Phenoxodiol may stop the growth of tumor cells by blocking the enzymes necessary for cancer cell growth.
PURPOSE: Phase I trial to study the effectiveness of phenoxodiol in treating patients who have refractory solid tumors.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose of phenoxodiol in patients with refractory solid tumors.
- Determine the steady-state pharmacokinetics of this drug in these patients.
- Determine the tumor response in patients treated with this drug.
OUTLINE: This is a multicenter, dose-escalation study.
Patients receive phenoxodiol IV continuously over days 1-7. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of phenoxodiol 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 toxicity.
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 or cytologically confirmed solid tumor
- •Refractory to standard therapy OR
- •No standard therapy exists
- •No breast cancer
- •No active CNS metastases
- •Known CNS metastases must be previously treated with radiotherapy or surgery and stable for at least 4 weeks prior to study
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Karnofsky 60-100%
- •Life expectancy:
- •At least 3 months
- •Hematopoietic:
- •Platelet count greater than 100,000/mm^3
- •WBC greater than 3,000/mm^3
- •Neutrophil count greater than 1,500/mm^3
- •Hemoglobin greater than 10 g/dL (9 g/dL for women)
- •Bilirubin less than 1.2 mg/dL
- •Transaminases no greater than 3 times upper limit of normal
- •Creatinine no greater than 1.4 mg/dL
- •No active infection
- •No contraindication to the insertion of a vascular access device
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No concurrent systemic anticancer immunotherapy
- •Chemotherapy:
- •No concurrent systemic anticancer chemotherapy
- •Endocrine therapy:
- •No concurrent systemic anticancer hormonal therapy except luteinizing hormone-releasing hormone agonists or antagonists
- •Radiotherapy:
- •See Disease Characteristics
- •Concurrent localized radiotherapy for control of local disease complications allowed
- •See Disease Characteristics
- •Recovered from prior antineoplastic therapy
- •At least 4 weeks since prior investigational agents
- •No other concurrent investigational drugs
排除标准
- 未提供
研究者
研究点 (1)
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