NCT00253344已完成1 期
Phase I Trial of Daily Lenalidomide (CC-5013, Revlimid™) and Docetaxel Given Every Three Weeks in Patients With Advanced Solid Tumors
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose
研究概览
简要总结
RATIONALE: Lenalidomide may stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide together with docetaxel may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of lenalidomide when given together with docetaxel in treating patients with advanced solid tumors.
详细描述
OBJECTIVES:
Primary
- Determine the dose-limiting toxicity and maximum tolerated dose of lenalidomide when given in combination with docetaxel in patients with advanced solid tumors.
Secondary
- Determine the safety of this regimen in these patients.
- Determine the objective tumor response in patients treated with this regimen.
- Determine the time to progression in patients treated with this regimen.
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 solid tumor
- •Advanced disease
- •Refractory to standard therapy OR no standard therapy exists
- •Measurable or evaluable disease
- •No active brain metastases
- •Previously treated (e.g., surgery or radiotherapy) brain metastases are allowed provided they are currently asymptomatic and inactive by CT scan or MRI
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Life expectancy
- •At least 4 months
- •Hematopoietic
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Hemoglobin ≥ 8 g/dL
- •Bilirubin normal
- •Meets 1 of the following criteria:
- •Alkaline phosphatase (AP) normal AND AST or ALT ≤ 5 times upper limit of normal (ULN)
- •AP ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN
- •AP ≤ 5 times ULN AND AST or ALT normal
- •Creatinine ≤ 2 mg/dL
- •Cardiovascular
- •No New York Heart Association class III or IV heart disease
- •Immunologic
- •No prior desquamating rash or ≥ grade 2 allergic reaction while receiving thalidomide
- •No history of hypersensitivity to docetaxel or other drugs formulated in polysorbate 80
- •No history of allergic reaction to compounds of similar chemical or biologic composition to study drugs
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No other uncontrolled illness or other condition that would preclude study compliance
- •No peripheral neuropathy ≥ grade 2
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No concurrent hematopoietic growth factors during course 1 of study treatment
- •No concurrent immunotherapy
- •Chemotherapy
- •At least 6 weeks since prior mitomycin or nitrosoureas
- •No more than 2 prior courses of mitomycin
- •No other concurrent chemotherapy
- •Radiotherapy
- •No prior pelvic radiotherapy
- •At least 4 weeks since prior anticancer therapy
- •No concurrent warfarin for anticoagulation (heparin is allowed)
- •Recovered from all prior treatment
- •No other concurrent anticancer therapy except bisphosphonates
- •No other concurrent investigational agents
排除标准
- 未提供
结局指标
主要结局
Maximum tolerated dose
时间窗: measured at end of phase I
Dose-limiting toxicity
时间窗: measured after every course
次要结局
- Disease response(measured after every 2 courses)
研究者
研究点 (1)
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