A Phase I Study Of Fenretinide Combined With Paclitaxel And Cisplatin For The Treatment Of Refractory Solid Tumors
试验速览
- 阶段
- 1 期
- 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 fenretinide, paclitaxel, and cisplatin in treating patients who have solid tumors that have not responded to previous therapy.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose, clinical toxicity, and recommended phase II dose of fenretinide when combined with paclitaxel and cisplatin in patients with refractory solid tumors.
- Determine the pharmacokinetics of this regimen in these patients.
- Determine the therapeutic response to this regimen in these patients.
OUTLINE: This is a dose escalation, multicenter study of fenretinide.
Patients receive oral fenretinide twice daily on days 1-7 and paclitaxel IV over 3 hours followed by cisplatin IV over 2 hours on day 2. On day 8 of course 1, patients also receive fenretinide once in the morning. Treatment repeats every 3 weeks for a maximum of 8 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response receive 2 additional courses.
Cohorts of 3-6 patients receive escalating doses of fenretinide 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 proven refractory solid tumor for which paclitaxel and cisplatin are reasonable therapeutic options
- •No active CNS disease
- •CNS metastasis allowed if measurable disease outside of the CNS and patient completed and recovered from 1 prior course of CNS radiotherapy (if clinically indicated)
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •ECOG 0-2 OR
- •Zubrod 0-2
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Platelet count at least 100,000/mm3
- •Absolute neutrophil count at least 1,500/mm3
- •Bilirubin no greater than 2.0 mg/dL
- •ALT and AST no greater than 2.5 times upper limit of normal (ULN) (5 times ULN if related to liver metastases)
- •Creatinine no greater than 1.5 mg/dL
- •Cardiovascular:
- •No severe symptomatic cardiac disease
- •No clinically significant/evident retinopathy
- •No other malignancy within the past 5 years except localized nonmelanoma skin cancer or carcinoma in situ of the cervix
- •No uncontrolled infection
- •No other significant medical or psychiatric condition that would increase risk
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception for 1 month before, during, and for at least 2 months after study
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •See Disease Characteristics
- •No prior paclitaxel, cisplatin, or fenretinide
- •At least 4 weeks since other prior chemotherapy
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •See Disease Characteristics
- •At least 4 weeks since prior radiotherapy to only site of measurable/evaluable disease
- •No prior radiotherapy to more than 25% of bone marrow
- •At least 2 weeks since prior therapeutic surgery and recovered
- •At least 4 weeks since prior routine vitamin A of at least 10,000 IU/ day or beta carotene of at least 10 mg/day
排除标准
- 未提供