Phase II Evaluation of Ifosfamide Plus Doxorubicin & Filgrastim Versus Gemcitabine Plus Docetaxel & Filgrastim in the Treatment of Localized Poor Prognosis Soft Tissue Sarcoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Percentage of Patients Hospitalized in Each Arm.
研究概览
简要总结
The purpose of this study is to explore how a sarcoma is affected by and the side effects of a newer combination of chemotherapy drugs(gemcitabine and docetaxel)as compared to a standard combination of chemotherapy drugs, ifosfamide and doxorubicin.
详细描述
The purpose of this study is to explore the relative activity and toxicity of a newer combination of chemotherapy drugs, gemcitabine and docetaxel, as compared to a standard combination of chemotherapy drugs, ifosfamide and doxorubicin.
Ifosfamide and Doxorubicin, given in combination, are recognized as a standard of care for some types of sarcoma. Both gemcitabine and docetaxel are approved by the US Food and Drug Administration (FDA) for the treatment of some cancers (cancers of the pancreas, lung) because patients with those cancers treated with either gemcitabine or docetaxel experienced shrinkage of their tumor or improvement in their symptoms. However, neither gemcitabine or docetaxel is approved for sarcoma, but the combination of gemcitabine and docetaxel is a standard treatment for advanced sarcoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •no evidence of metastasis
- •soft tissue sarcoma
- •intermediate or high histologic grade
- •greater than 5 cm
- •Zubrod performance status 1 or better
- •age 10 or older
排除标准
- •clear cell, alveolar soft part, Ewing's rhabdosarcoma, undifferentiated small cell or Kaposi's
- •prior chemotherapy
- •nephrectomy
- •active unstable angina pectoris
- •concurrent therapy
研究组 & 干预措施
doxorubicin and ifosfamide
干预措施: ifosfamide and doxorubicin vs gemcitabine and docetaxel (Drug)
gemcitabine and docetaxel
干预措施: ifosfamide and doxorubicin vs gemcitabine and docetaxel (Drug)
结局指标
主要结局
Percentage of Patients Hospitalized in Each Arm.
时间窗: 12 weeks
To contrast the proportion of treated patients hospitalized subsequent to treatment with gemcitabine and docetaxel as compared to doxorubicin and ifosfamide as neoadjuvant or adjuvant therapy of poor prognosis soft tissue sarcoma.
次要结局
- The Percentage of Patients Alive Without Disease at 2 Years(2 years)