Phase IB Study of Gemcitabine, Docetaxel and Bevacizumab in Patients With Soft Tissue Sarcoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 4
- 主要终点
- Overall response rate (complete and partial responses).
研究概览
简要总结
1.1 To determine the recommended phase II dose for gemcitabine in combination with a fixed dose of docetaxel and bevacizumab.
1.2 To determine the efficacy of the combination of gemcitabine, docetaxel, and bevacizumab in patients with soft tissue sarcoma 1.3 To determine the toxicity profile of the combination of gemcitabine, docetaxel, and bevacizumab in patients with soft tissue sarcoma
详细描述
Because the combination of gemcitabine and docetaxel has shown impressive activity in soft tissue sarcoma, we hypothesize that the addition of an antiangiogenesis agent (bevacizumab) would enhance the anticancer activity, as shown in other tumor types.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Patients with symptomatic brain metastases are excluded from this study.
- •Pregnant women or nursing mothers are not eligible for this trial. Patients of child bearing potential must use adequate contraception.
- •Patients may receive no other concurrent chemotherapy or radiation therapy during this trial.
- •Patients with severe medical problems such as uncontrolled diabetes mellitus or cardiovascular disease or active infections are not eligible for this trial.
研究组 & 干预措施
Cohort 1
1000mg/m2 gemcitabine
干预措施: Gemcitabine, Docetaxel and Bevacizumab (Drug)
Cohort 2
1250 mg/m2 gemcitabine
干预措施: Gemcitabine, Docetaxel and Bevacizumab (Drug)
Cohort 3
1500 mg/m2 gemcitabine
干预措施: Gemcitabine, Docetaxel and Bevacizumab (Drug)
结局指标
主要结局
Overall response rate (complete and partial responses).
时间窗: 4 years
Tumor response is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). ORR is the sum of the percentages of patients achieving complete and partial responses
次要结局
未报告次要终点