Phase I Pharmacokinetic Trial of Thalidomide and Docetaxel: A Regimen Based on Anti-Angiogenic Therapeutic Principles
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Determine the maximum tolerated dose of docetaxel when administered with thalidomide in patients with advanced solid tumors, multiple myeloma, and non-Hodgkin's lymphoma.
研究概览
简要总结
RATIONALE: Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining thalidomide with docetaxel may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining thalidomide with docetaxel in treating patients who have advanced cancer.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose of docetaxel when administered with thalidomide in patients with advanced solid tumors, multiple myeloma, and non-Hodgkin's lymphoma.
- Determine the dose-limiting toxicity and safety profile of this regimen in these patients.
- Determine the plasma pharmacokinetics of this regimen in these patients.
- Determine the objective tumor response and prolonged freedom from progression in patients treated with this regimen.
OUTLINE: This is a dose-escalation study.
Patients receive oral thalidomide twice daily and docetaxel IV over 30 minutes once weekly. Courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of docetaxel and thalidomide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 1 of 3 or 2 of 6 patients experience dose-limiting toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 malignancy not amenable to curative surgery, radiotherapy, or chemotherapy
- •Tumor types may include any of the following:
- •Any solid tumor including, but not limited to, head and neck, breast, lung, gastrointestinal, genitourinary, melanoma, and sarcoma
- •Primary CNS neoplasms if the following are true:
- •Received primary radiotherapy
- •No concurrent corticosteroids or has been on a stable corticosteroid dose for at least 30 days
- •No concurrent enzyme-inducible anti-epileptic medications (i.e., carbamazepine or phenytoin)
- •Multiple myeloma
- •Non-Hodgkin's lymphoma
- •No refractory or relapsed acute or chronic leukemia
- •Measurable or evaluable disease
- •No life-prolonging therapy available
- •Hormone receptor status:
- •Not specified
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Male or female
- •Menopausal status
- •Not specified
- •Performance status
- •Life expectancy
- •At least 4 months
- •Hematopoietic
- •WBC at least 4,000/mm^3
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Hemoglobin at least 10 g/dL
- •Bilirubin no greater than upper limit of normal (ULN)
- •AST and/or ALT no greater than 2.5 times ULN if alkaline phosphatase less than ULN OR
- •Alkaline phosphatase no greater than 4 times ULN if AST/ALT less than ULN
- •Creatinine no greater than 1.5 mg/dL OR
- •Creatinine clearance at least 60 mL/min
- •Cardiovascular
- •No New York Heart Association class III or IV heart disease
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use 2 effective methods of contraception 4 weeks before, during, and 4 weeks after study
- •Willing and able to comply with FDA-mandated STEPS program
- •No peripheral neuropathy grade 2 or greater
- •No prior severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
- •No more than 2 prior courses of mitomycin
- •Endocrine therapy
- •See Disease Characteristics
- •Radiotherapy
- 另有 3 项未显示
排除标准
- 未提供
结局指标
主要结局
Determine the maximum tolerated dose of docetaxel when administered with thalidomide in patients with advanced solid tumors, multiple myeloma, and non-Hodgkin's lymphoma.
时间窗: Weekly courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.
次要结局
未报告次要终点