NCT00415116已完成1 期
Phase I Trial of Three-Weekly Docetaxel, Carboplatin and Oral CC-5013 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
- 14
- 主要终点
- Dose-limiting toxicity of lenalidomide
研究概览
简要总结
RATIONALE: Lenalidomide may stop the growth of solid tumors by blocking blood flow to the tumor. Drugs used in chemotherapy, such as docetaxel and carboplatin, 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 and carboplatin 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 and carboplatin in treating patients with advanced solid tumors.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of lenalidomide when administered with docetaxel and carboplatin in patients with advanced solid tumors.
Secondary
- Determine the safety and toxic effects of this regimen in these patients.
- Determine, preliminarily, the clinical activity of this regimen in these patients.
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 or cytologically proven solid tumor
- •Measurable or evaluable disease
- •Refractory to standard treatment
- •No prior failure of a docetaxel and carboplatin regimen except in the adjuvant setting
- •History of brain disease allowed, provided the following criteria are met:
- •Brain disease previously treated with radiotherapy or surgery
- •Asymptomatic with no active brain disease, as documented by CT scan or MRI, for at least 3 months
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Creatinine ≤ 1.5 mg/dL
- •Bilirubin normal
- •AST and ALT ≤ 2 times upper limit of normal (ULN) (5 times ULN if hepatic metastases are present)
- •Alkaline phosphatase ≤ 3 times ULN
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 4 weeks after completion of study treatment
- •No serious medical condition, laboratory abnormality, or psychiatric illness that would preclude giving informed consent, expose the patient to unacceptable risk, or affect the interpretation of study data
- •No known hypersensitivity to thalidomide
- •No history of erythema nodosum, characterized by a desquamating rash, while taking thalidomide or similar drugs
- •No pre-existing peripheral neuropathy ≥ grade 2
- •No known hypersensitivity or intolerance to taxanes
- •No known HIV positivity
- •No known infectious hepatitis, types A, B, or C
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •No more than 2 prior chemotherapy regimens
- •At least 28 days since prior cancer therapy, including radiotherapy, biologic therapy, hormonal therapy, chemotherapy, or surgery
- •At least 28 days since any other prior investigational drug or therapy
- •No prior lenalidomide
- •No other concurrent chemotherapy or biologic therapy
- •No concurrent radiotherapy
- •No concurrent use of any other anticancer agents or treatments
- •No prophylactic granulocyte colony-stimulating factors (G-CSF) during the first course of study treatment
- •No concurrent prophylactic antibiotics
- •No concurrent treatment with the following medications:
- •Systemic corticosteroids (except as prophylaxis for docetaxel administration)
- •Estrogens
- •Macrolides
- •Cyclosporine
- •Phenytoin
排除标准
- 未提供
结局指标
主要结局
Dose-limiting toxicity of lenalidomide
Maximum tolerated dose of lenalidomide
次要结局
- Clinical activity
- Safety and toxicity
研究者
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