Single Center Open-Label Non-Comparative Phase I Dose Finding Study Of Weekly Flavopiridol In Combination With Weekly Docetaxel In Patients With Advanced Solid Tumors
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: 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 with docetaxel in treating patients who have advanced solid tumors.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose of flavopiridol when administered in combination with 2 different doses of docetaxel in patients with advanced solid tumors.
- Determine the clinical pharmacokinetics of this regimen in these patients.
- Determine, preliminarily, the therapeutic activity of this regimen in these patients.
OUTLINE: This is a dose-escalation study of flavopiridol.
Patients receive docetaxel IV over 30 minutes followed at least 4 hours later by flavopiridol IV over 1 hour on days 1, 8, and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity. Separate MTDs of flavopiridol are determined when flavopiridol is combined with 2 different doses of docetaxel. A total of 10 patients are treated at each flavopiridol MTD.
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 advanced solid tumor that is refractory to standard therapy or for which no standard therapy exists
- •Measurable or evaluable disease
- •No symptomatic or untreated CNS metastases or primary CNS neoplasm
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Karnofsky 70-100%
- •Life expectancy
- •Not specified
- •Hematopoietic
- •WBC at least 3,500/mm3
- •Absolute neutrophil count at least 1,500/mm3
- •Platelet count at least 100,000/mm3
- •Hemoglobin at least 8 g/dL
- •Bilirubin no greater than upper limit of normal (ULN)
- •SGOT/SGPT no greater than 2.5 times ULN if alkaline phosphatase no greater than ULN OR
- •Alkaline phosphatase no greater than 2.5 times ULN if SGOT/SGPT no greater than ULN
- •Creatinine no greater than 1.5 mg/dL
- •Cardiovascular
- •No history of cardiac arrhythmias
- •No congestive heart failure
- •No myocardial infarction within the past 6 months
- •No concurrent serious or uncontrolled infection
- •No diabetes not adequately controlled with medication
- •No peripheral neuropathy greater than grade 1
- •No known allergy to docetaxel or other medications formulated in Polysorbate 80
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 2 months after study
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •At least 4 weeks since prior immunotherapy
- •Chemotherapy
- •At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
- •Prior taxanes allowed
- •No prior flavopiridol
- •Endocrine therapy
- •At least 4 weeks since prior hormonal therapy
- •Radiotherapy
- •At least 4 weeks since prior radiotherapy
- •Not specified
- •Recovered from prior therapy
- •No prior enrollment in this study
排除标准
- 未提供