A Phase II Study of Biweekly Gemcitabine and Paclitaxel (GEMTAX) Combination in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 122
- 主要终点
- Overall Survival
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving gemcitabine together with paclitaxel may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving gemcitabine together with paclitaxel works in treating patients with persistent, recurrent, or metastatic head and neck cancer.
详细描述
OBJECTIVES:
- Determine overall and progression-free survival probability in patients with persistent, recurrent, or metastatic squamous cell carcinoma of the head and neck treated with gemcitabine and paclitaxel.
- Determine the confirmed and unconfirmed response (partial and complete) probability in patients with measurable disease treated with this regimen.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive gemcitabine IV over 30 minutes and paclitaxel IV over 1 hour on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 4 additional courses beyond CR.
Patients are followed every 8 weeks until disease progression, every 6 month for 2 years, and then annually for 1 year.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
gemcitabine paclitaxel combination
干预措施: gemcitabine (Drug)
gemcitabine paclitaxel combination
干预措施: paclitaxel (Drug)
结局指标
主要结局
Overall Survival
时间窗: 0 - 3 years
Measured from time of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.
次要结局
- Progression-free Survival(0 - 3 years)
- Response(9 weeks - 3 years)
- Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug(Patients were assessed for adverse events after the first cycle of treatment and then every three months while on treatment.)