Phase I Dose Escalation Study of UCN-01 (NSC 638850) Plus Cisplatin in Advanced Malignant Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 试验地点
- 8
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 UCN-01 and cisplatin in treating patients who have advanced or metastatic solid tumors.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose of cisplatin when administered with UCN-01 in patients with advanced solid tumors.
- Assess the toxicity and potential antitumor activity of this regimen in these patients.
- Determine the pharmacokinetics of this regimen in these patients.
OUTLINE: This is a dose-escalation, multicenter study of cisplatin.
Patients receive cisplatin IV over 1 hour on day 1 and UCN-01 IV continuously over 36-72 hours beginning on day 2. Treatment continues every 4 weeks for a total of 6 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 1-6 patients receive escalating doses of cisplatin 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 advanced or metastatic solid tumor incurable by surgery or other standard therapy
- •Tumor site accessible by biopsy
- •No brain metastasis
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Karnofsky 60-100%
- •Life expectancy:
- •More than 3 months
- •Hematopoietic:
- •WBC at least 4,500/mm3
- •Absolute neutrophil count at least 2,000/mm3
- •Platelet count at least 150,000/mm3
- •Bilirubin normal
- •SGOT no greater than 2.5 times upper limit of normal
- •Creatinine normal
- •Creatinine clearance at least 60 mL/min
- •Cardiovascular:
- •No New York Heart Association class III or IV congestive heart failure
- •No peripheral neuropathy greater than grade I
- •No history of allergic reactions to diuretics or antiemetics (e.g., 5-HT3 antagonists) that would preclude study
- •No other uncontrolled illness that would preclude study, including intolerance to vigorous hydration
- •No medical, social, or psychological factors that would preclude study
- •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 mitomycin or nitrosoureas) and recovered
- •No greater than 2 prior chemotherapy regimens
- •Prior cisplatin allowed if cumulative dose no greater than 400 mg/m2
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •At least 4 weeks since prior radiotherapy and recovered
- •No concurrent radiotherapy
- •See Disease Characteristics
- •Recovered from any prior surgery
- •At least 30 days since prior investigational drugs
- •No other concurrent investigational drugs
- •No other concurrent anticancer agents
排除标准
- 未提供