Phase I Trial of Abraxane in Combination With Gemcitabine in Patients With Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Dose Limiting Toxicity (DLT)
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation and gemcitabine, 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 paclitaxel albumin-stabilized nanoparticle formulation when given together with gemcitabine in treating patients with advanced metastatic solid tumors.
详细描述
OBJECTIVES:
Primary
- Determine the dose-limiting toxicity and maximum tolerated dose of paclitaxel albumin-stabilized nanoparticle formulation (Abraxane) in combination with gemcitabine hydrochloride in patients with advanced metastatic solid tumors.
Secondary
- Evaluate the efficacy 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 confirmed solid tumors
- •Advanced metastatic disease
- •Measurable or evaluable disease
- •Must meet 1 of the following criteria:
- •Failed prior standard therapy
- •Not a candidate for standard therapy
- •Has a disease for which there is no defined standard therapy
- •No symptomatic brain metastases
- •PATIENT CHARACTERISTICS:
- •ECOG functional status 0-2
- •Life expectancy ≥ 8 weeks
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count > 100,000/mm^3
- •Hemoglobin ≥ 9.0 g/dL
- •Bilirubin normal
- •Creatinine ≤ 1.5 times upper limit of normal (ULN) OR creatinine clearance ≥ 60 mL/min
- •AST and ALT ≤ 2.5 times ULN
- •Not pregnant or nursing
- •Negative pregnancy test
- •No prior anaphylactic reaction or severe allergic reaction to paclitaxel, docetaxel, or gemcitabine hydrochloride
- •No active infectious process that will require treatment with antibiotics for > 4 weeks
- •No uncontrolled congestive heart failure
- •No symptomatic coronary artery disease or heart block
- •No myocardial infarction within the past 3 months
- •No peripheral neuropathy ≥ grade 2 from any cause
- •PRIOR CONCURRENT THERAPY:
- •More than 3 weeks since prior chemotherapy, radiotherapy, or any other treatment
- •No prior radiotherapy to > 25% of bone marrow
- •No prior nitrosoureas
- •No more than 6 prior courses of alkylating agents
- •No more than 2 prior courses of mitomycin C
- •No more than 3 prior courses of cytotoxic therapy for metastatic disease
- •No concurrent filgrastim (G-CSF), pegfilgrastim, or sargramostim (GM-CSF) during study course 1
排除标准
- 未提供
结局指标
主要结局
Dose Limiting Toxicity (DLT)
时间窗: 21 days
Toxicity will be graded using the CTCAE version 3.0 and will be assessed on cycle one (21 days)
Maximum Tolerated Dose(MTD)
时间窗: 1 year
If greater than or equal to 2 of 6 patients (33%) experience a DLT, then that dose level will be considered to have excessive toxicity and will = MTD
次要结局
- Radiographic Response to Treatment(every 42 days)