A Phase I/II Study of Gemcitabine (GEMZAR)/Vinorelbine (NAVELBINE)/Liposomal Doxorubicin (DOXIL) in Relapsed/Refractory Hodgkin's Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 76
- 主要终点
- Overall response rate
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/II trial to study the effectiveness of combination chemotherapy in treating patients who have relapsed or refractory Hodgkin's lymphoma.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose and toxicity of gemcitabine, vinorelbine, and doxorubicin HCl liposome in patients with relapsed or refractory Hodgkin's lymphoma.
- Determine the complete and partial response rates of patients treated with this regimen.
OUTLINE: This is a dose-escalation, multicenter study.
Phase I:
- Patients receive vinorelbine IV over 6-10 minutes, gemcitabine IV over 30 minutes, and doxorubicin HCl liposome IV over 30-60 minutes on days 1 and 8. Treatment continues every 21 days for 2-6 courses in the absence of unacceptable toxicity or disease progression. Patients who respond to treatment after 2 or more courses may stop protocol therapy to undergo peripheral blood stem cell transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
vinorelbine + gemcitabine + doxorubicin - higher doses
Patients who have not undergone prior transplantation receive vinorelbine, gemcitabine, and doxorubicin HCl liposome.
Patients are followed every 6 months for 2 years and then annually for 6 years.
干预措施: gemcitabine hydrochloride (Drug)
vinorelbine + gemcitabine + doxorubicin - higher doses
Patients who have not undergone prior transplantation receive vinorelbine, gemcitabine, and doxorubicin HCl liposome.
Patients are followed every 6 months for 2 years and then annually for 6 years.
干预措施: pegylated liposomal doxorubicin hydrochloride (Drug)
vinorelbine + gemcitabine + doxorubicin - higher doses
Patients who have not undergone prior transplantation receive vinorelbine, gemcitabine, and doxorubicin HCl liposome.
Patients are followed every 6 months for 2 years and then annually for 6 years.
干预措施: vinorelbine tartrate (Drug)
vinorelbine + gemcitabine + doxorubicin - lower doses
Patients who have undergone prior transplantation receive lower doses of vinorelbine, gemcitabine, and doxorubicin HCl liposome.
Patients are followed every 6 months for 2 years and then annually for 6 years.
干预措施: gemcitabine hydrochloride (Drug)
vinorelbine + gemcitabine + doxorubicin - lower doses
Patients who have undergone prior transplantation receive lower doses of vinorelbine, gemcitabine, and doxorubicin HCl liposome.
Patients are followed every 6 months for 2 years and then annually for 6 years.
干预措施: pegylated liposomal doxorubicin hydrochloride (Drug)
vinorelbine + gemcitabine + doxorubicin - lower doses
Patients who have undergone prior transplantation receive lower doses of vinorelbine, gemcitabine, and doxorubicin HCl liposome.
Patients are followed every 6 months for 2 years and then annually for 6 years.
干预措施: vinorelbine tartrate (Drug)
结局指标
主要结局
Overall response rate
时间窗: Up to 4 years
次要结局
- Overall survival(Up to 4 years)