A Phase I Trial of Daily Bolus Flavopiridol for Five Consecutive Days in Patients With Refractory Neoplasms
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.
PURPOSE: Phase I trial to study the effectiveness of flavopiridol in treating patients who have refractory cancer.
详细描述
OBJECTIVES: I. Determine the dose-limiting toxicity and maximum tolerated dose of flavopiridol in patients with refractory solid tumors or lymphoma. 2. Determine the pharmacokinetics of this drug in these patients.
OUTLINE: This is a dose-escalation study. Patients receive flavopiridol IV over 1 hour on day 1. Treatment continues every 3 weeks in the absence of disease progression. A cohort of 3-6 patients receives treatment at each dose level of flavopiridol. If dose-limiting toxicity (DLT) occurs in no more than 1 of 6 patients, subsequent cohorts of 6 patients each receive escalating doses of drug on the same schedule. Intrapatient dose escalation to the next level is permitted in the absence of DLT.
PROJECTED ACCRUAL: Approximately 36 patients will be accrued for this study within 27 months.
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 proven refractory solid tumor or lymphoma requiring systemic therapy No standard therapeutic options exist Prostate cancer patients: Tumor progression during blockade of testicular and adrenal androgen required PSA elevation on 2 consecutive blood samples, 2 weeks apart Serum testosterone concentrations in the castrate range Leuprolide or other gonadotropin-releasing hormone (GnRH) analogs maintained if no prior orchiectomy No CNS neoplasms
- •PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Platelet count at least 75,000/mm3 Absolute granulocyte count at least 1,000/mm3 No active coagulopathy requiring therapeutic anticoagulation Hepatic: SGOT and SGPT no greater than 2.5 times normal Bilirubin no greater than 1.5 times normal (3 times normal if Gilbert's disease present) Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No history of unstable or newly diagnosed angina pectoris No myocardial infarction within past 6 months No New York Heart Association class II-IV heart disease Other: No serious concurrent medical illness HIV negative Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study
- •PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered No prior flavopiridol Endocrine therapy: See Disease Characteristics A least 4 weeks since prior flutamide or other antiandrogen therapy without disease improvement At least 4 weeks since prior hormonal therapy for breast carcinoma and must show evidence of disease progression No concurrent corticosteroids except for physiological replacement Radiotherapy: At least 4 weeks since prior radiotherapy and recovered At least 6 weeks since prior bone-seeking radioisotope therapy Surgery: Not specified Other: At least 3 months since prior suramin treatment At least 2 months since prior UCN-01 No concurrent anticoagulation therapy No other concurrent antineoplastic therapy except for GnRH for prostate cancer
排除标准
- 未提供