NCT00016185已完成1 期
Phase I Study Of Flavopiridol And Docetaxel (Taxotere) In Patients With Advanced Cancers
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining flavopiridol and docetaxel in treating patients who have advanced solid tumors.
详细描述
OBJECTIVES:
- Determine the dose-limiting toxic effects and maximum tolerated dose of flavopiridol and docetaxel in patients with advanced solid tumors.
- Determine the objective response rate and duration of response in patients treated with this regimen.
- Determine the pharmacokinetics of these drugs in this patient population.
OUTLINE: This is a dose-escalation study.
Patients receive docetaxel IV over 60 minutes on day 1 and flavopiridol IV continuously over 24 hours on day 2. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of docetaxel and flavopiridol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 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 metastatic or unresectable solid tumor
- •No standard relatively effective curative or palliative measures exist
- •Measurable disease in at least 1 dimension
- •At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
- •No known clinically active and uncontrolled brain metastases
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Karnofsky 60-100%
- •Life expectancy:
- •More than 12 weeks
- •Hematopoietic:
- •WBC at least 3,000/mm^3
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin normal
- •ALT/AST no greater than 1.5 times upper limit of normal (ULN)
- •Alkaline phosphatase no greater than 2.5 times ULN
- •Creatinine normal
- •Cardiovascular:
- •No symptomatic congestive heart failure
- •No unstable angina pectoris
- •No cardiac arrhythmia
- •No prior allergic reactions to compounds of similar chemical or biologic composition to flavopiridol or docetaxel
- •No other uncontrolled concurrent illness that would preclude study participation
- •No ongoing or active infection
- •No psychiatric illness or social situations that would preclude study compliance
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No concurrent immunotherapy
- •Chemotherapy:
- •At least 6 months since prior taxane therapy
- •At least 4 weeks since other prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
- •No other concurrent chemotherapy
- •Endocrine therapy:
- •No concurrent hormonal therapy except contraceptives, appetite stimulants, or replacement steroids
- •Radiotherapy:
- •At least 4 weeks since prior radiotherapy and recovered
- •No concurrent radiotherapy
- •See Disease Characteristics
- •No other concurrent investigational agents
- •No concurrent combination antiretroviral therapy for HIV-positive patients
排除标准
- 未提供
研究者
研究点 (2)
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