Phase I Trial of Combination Pegylated Liposomal Doxorubicin (Doxil), Vinorelbine, and Gemcitabine
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy in treating patients who have advanced solid tumors.
详细描述
OBJECTIVES:
- Determine the pharmacokinetic profile of gemcitabine, doxorubicin HCl liposome, and vinorelbine in patients with advanced solid tumors.
- Determine the maximum tolerated dose of this regimen in these patients.
- Determine the toxicity profile of this regimen in these patients.
OUTLINE: This is a dose escalation study.
Patients receive doxorubicin HCl liposome IV over 1-2.5 hours on day 1, gemcitabine IV over 30 minutes on days 1 and 8, and vinorelbine IV over 6-10 minutes on days 1 and 15. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of doxorubicin HCl liposome, gemcitabine, and vinorelbine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 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 solid tumor not amenable to curative surgery, radiotherapy, or chemotherapy
- •No brain metastases or primary brain tumors
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •At least 12 weeks
- •Hematopoietic:
- •WBC at least 3,500/mm3
- •Absolute neutrophil count at least 1,500/mm3
- •Platelet count at least 100,000/mm3
- •Hemoglobin greater than 10 g/dL
- •Bilirubin no greater than 1.2 mg/dL
- •AST and/or ALT less than 2.5 times upper limit of normal (ULN)
- •PT no greater than ULN (anticoagulant independent)
- •Creatinine no greater than 1.5 mg/dL AND/OR
- •Creatinine clearance greater than 60 mL/min
- •Cardiovascular:
- •No New York Heart Association class III or IV heart disease
- •LVEF at least 45% by MUGA or echocardiogram
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No prior bone marrow or peripheral blood stem cell transplantation following high dose chemotherapy
- •At least 3 weeks since prior biologic therapy for cancer and recovered
- •No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)
- •Chemotherapy:
- •See Disease Characteristics
- •See Biologic therapy
- •No more than 1 prior chemotherapy regimen
- •No prior vinca alkaloids
- •Prior anthracycline allowed if total dose no greater than 300 mg/m2
- •At least 3 weeks since prior chemotherapy (6 weeks for mitomycin or carmustine) and recovered
- •Endocrine therapy:
- •At least 3 weeks since prior endocrine therapy for cancer and recovered
- •Radiotherapy:
- •See Disease Characteristics
- •No more than 1 prior radiotherapy regimen
- •At least 4 weeks since prior large field radiotherapy
- •At least 3 weeks since prior radiotherapy for cancer and recovered
- •Not specified
排除标准
- 未提供