A Phase II Study of Gemcitabine in Combination With Doxorubicin for Patients With Head and Neck Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Response Rate
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and doxorubicin, 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 II trial is studying how well giving gemcitabine together with doxorubicin works in treating patients with recurrent or progressive head and neck cancer.
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 120 Years（Adult, Older Adult）
- 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
Gemcitabine+doxorubicin
干预措施: gemcitabine hydrochloride (Drug)
Gemcitabine+doxorubicin
干预措施: doxorubicin hydrochloride (Drug)
结局指标
主要结局
Response Rate
时间窗: Every 6 weeks from the time of initial treatment for up to 8 months
Per Response Evaluation Criteria in Solid Tumors (RECIST) for target lesions assessed by CT or MRI: Complete Response (CR) is the disappearance of all target lesions (TL) and non-target lesions (NTL); Partial Response (PR) is defined by either a CR of TL and stable disease (SD) in NTL or PR of TL and non-progressive disease (PD) in NTL. Response rate is the sum of CR + PR as defined above.
次要结局
- Correlation of Cytotoxicity With Apoptosis in Cancer Cells(prior to first dose of drug and every 6 weeks for up to 6 months)
- Duration of Response(Every 6 weeks for up to 8 months)
- Progression-free Survival(Through the end of follow up, for an average of 8 months)
- Number of Patients Who Had Greater Than Grade 2 Toxicity(from time of initial treatment until end of study, an average of 6 months)
- Overall Survival(From the time of initial therapy until the time of death.)
- Correlation of Cytoxocity With Cell-cycle Arrest(prior to first dose of drug and every 6 weeks up to 6 months)