Phase I/II Study of the Combination of Docetaxel, Gemcitabine and Pazopanib for Neoadjuvant Treatment of Patients With Operable Soft Tissue Sarcoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Maximum Tolerated Dose
研究概览
简要总结
Chemotherapy treatment with docetaxel and gemcitabine is a standard treatment for patients with soft tissue sarcoma. This study is designed to explore whether the addition of tyrosine kinase inhibitor pazopanib enhances the anticancer effect of the chemotherapy drugs.
The Phase I component of this study is designed to determine the maximum tolerated dose of pazopanib when given with docetaxel and gemcitabine. The Phase II component is designed to determine the overall response rate of the combination of docetaxel, gemcitabine and pazopanib prior to surgical resection in patients with soft tissue sarcoma.
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
- •18 years or older
- •chemotherapy naive, histologically high grade soft tissue sarcoma that is considered to be operable
- •tumor greater than 5 cm in longest dimension
- •life expectancy of at least 6 months
- •Zubrod performance status of 0-2
- •signed informed consent
- •adequate bone marrow function defined by:
- •absolute peripheral granulocyte count of >1500 cells/mm^3
- •hemoglobin >8.0 g/dl
- •platelet count >100,000/mm^3
- •absence of a regular red blood cell transfusion requirement
- •adequate hepatic function defined by:
- •total bilirubin <1.5 x upper limit of normal (ULN)
- •AST, ALT and alkaline phosphatase all not more than 2.5 x ULN
- •adequate renal function defined by:
- •serum creatinine <1.5 x ULN
- •negative pregnancy test for women of child bearing potential
- •willingness to use effective contraception while on treatment and for 3 months thereafter
排除标准
- •Multiple metastases (patients with 5 or fewer oligometastases that could be resectable are eligible)
- •Pregnant women or nursing mothers
- •concurrent chemotherapy or radiation therapy
- •severe medical problems (at the discretion of the investigator)
- •history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
- •symptomatic brain metastases
- •cirrhosis
- •dermatofibrosarcoma protuberans (DFSP), embryonal rhabdomyosarcoma or alveolar soft part sarcoma (ASPS)
研究组 & 干预措施
cohort 1
干预措施: Gemcitabine (Drug)
cohort 1
干预措施: Docetaxel (Drug)
cohort 1
干预措施: Pazopanib (Drug)
结局指标
主要结局
Maximum Tolerated Dose
时间窗: 1 cycle (28 days)
次要结局
- Overall response rate(4 cycles (112 days))
研究者
Claire Verschraegen
Director, Hematology Oncology Unit
University of Vermont