NCT00401180已完成1 期
Phase I Trial of Weekly Docetaxel and Daily Temozolomide in Patients With Metastatic Disease
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Maximum tolerated dose
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as docetaxel and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of docetaxel and temozolomide in treating patients with metastatic cancer.
详细描述
OBJECTIVES:
Primary
- Determine the toxicity profile, dose-limiting toxicity, and maximum tolerated dose of docetaxel and temozolomide (TMZ) in patients with metastatic cancer.
Secondary
- Determine the activity of docetaxel and TMZ 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 confirmed diagnosis of a nonhematologic malignancy that is refractory to standard therapy OR for which no standard therapy is available
- •Measurable (by CT scan) or evaluable disease
- •If palliative radiotherapy has been administered, the measurable disease must be outside the radiation port
- •Prior brain metastasis allowed provided it was definitely treated with external-beam radiotherapy, gamma knife, or surgical resection and is clinically stable
- •Repeat MRI or CT scans must demonstrate stabilization of disease 4 weeks after the definitive therapy is completed AND there must be no requirement for dexamethasone
- •No active CNS metastasis
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •Life expectancy ≥ 4 months
- •Absolute granulocyte count ≥ 1,500/mm³
- •Platelet count ≥ 100,000/mm³
- •Hemoglobin ≥ 8.0 g/dL (epoetin alfa and/or transfusions allowed)
- •Creatinine ≤ 2 mg/dL
- •Bilirubin normal
- •PT normal, unless the patient is on warfarin for prior deep vein thrombosis or pulmonary embolus, requiring INR maintained at 2.0 - 3.0
- •Sodium and potassium normal
- •AST and ALT ≤ 1.5 times upper limit of normal (ULN)
- •Alkaline phosphatase ≤ 2.5 times ULN
- •No decompensated cardiac arrhythmia or other severe cardiovascular disease (i.e., New York Heart Association [NYHA] class III-IV heart disease)
- •Patients with clinically stable NYHA class III or IV heart disease require cardiac clearance
- •No peripheral neuropathy > grade 1
- •No infection requiring IV antibiotics within the past 14 days
- •No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
- •No HIV positivity
- •No hepatitis B surface antigen or hepatitis C antibody positivity
- •No pulmonary embolus within the past 3 weeks
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use 2 methods of effective contraception
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •No more than 3 courses of prior immunotherapy and/or chemotherapy for metastatic disease
- •Interferon alfa in the adjuvant setting is not considered a course of prior therapy
- •Patients who relapse on adjuvant interferon alfa must be off therapy for ≥ 3 weeks
- •No prior stem cell or organ transplantation
- •More than 21 days since prior immunotherapy or chemotherapy
- •At least 21 days since prior hormonal therapy (except luteinizing hormone-releasing hormone [LHRH] agonists) or radiotherapy and recovered
- •More than 21 days since prior surgery requiring general anesthesia
- •No concurrent radiotherapy
- •Concurrent LHRH agonist therapy allowed
- •Concurrent physiologic replacement steroids allowed
- •No other concurrent chemotherapy or thalidomide
- •No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF) during study chemotherapy
排除标准
- 未提供
结局指标
主要结局
Maximum tolerated dose
时间窗: 4 cycles
Dose-limiting toxicity
时间窗: 4 cycles
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
已完成
2 期
Docetaxel and Carboplatin in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Peritoneal Cavity CancerFallopian Tube CancerPrimary Peritoneal Cavity CancerOvarian CancerNCT00138242Floyd & Delores Jones Cancer Institute at Virginia Mason Medical Center30
已完成
2 期
Docetaxel and Cisplatin in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer That Has Been Completely Removed By SurgeryLung CancerNCT00281970Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins50
终止
2 期
Docetaxel and Cisplatin in Treating Patients With Stage III or Stage IV Non-Small Cell Lung CancerLung CancerNCT00118131University of Medicine and Dentistry of New Jersey49
已完成
1 期
Docetaxel and Imatinib Mesylate in Treating Patients With Locally Advanced or Metastatic Breast CancerBreast CancerNCT00080665Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins12
已完成
2 期
Docetaxel, Gemcitabine, and Filgrastim (G-CSF) or Pegfilgrastim in Treating Patients With Advanced, Persistent, or Recurrent Uterine LeiomyosarcomaSarcomaNCT00101127Gynecologic Oncology Group