Phase II Trial On Trabectedin In The Treatment Of Advanced Uterine And Ovarian Carcinosarcoma (CS)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
Multicenter phase II study on trabectedin in patients advanced uterine and ovarian carcinosarcoma. Patients will receive trabectedin until disease progression or unacceptable toxicity. Disease response evaluation will be assessed every 9 weeks.
详细描述
This is a Phase II, multi-centre, single arm study aiming at evaluating efficacy and toxicity of Trabectedin in a population of advanced or recurrent ovarian and uterine carcinosarcoma.
Trabectedin will be infused at the dose of 1.3 mg/m2 as a 3- hour iv infusion every 3 weeks via a central venous catheter.
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 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically documented Stage I-IV or recurrent uterine or ovarian carcinosarcoma not amenable to surgery or radiotherapy
- •No more than 2 previous chemotherapy lines
- •PS 0-2 (ECOG)
- •Measurable disease
- •Life expectancy of at least 3 months
- •Adequate organ functions:
- •Hematopoietic; Absolute neutrophil count ≥ 1,500/mm^3; Platelet count ≥ 100,000/mm^3; Hemoglobin ≥ 9 g/dL Hepatic; AST and ALT ≤ 1.5 times upper limit of normal (ULN)*; Protocol Version 1.0_05.09.2016 6 Alkaline phosphatase ≤ 2.5 times ULN*; Bilirubin ≤ 1.5 times ULN NOTE: * ≤ 3 times ULN if liver metastases are present Renal; Creatinine Clearance ≥ 45 mL/min or Serum Creatinine ≤1.5 x ULN Serum Albumin >3.0 g/dL
- •Previous Brachytherapy treatment for uterine carcinosarcoma is allowed
- •No other invasive malignancy within the past 3 years except non-melanoma skin cancer
- •Written Informed Consent
排除标准
- •More than 2 previous chemotherapy lines
- •Single tumor lesion inside a previous irradiated filed
- •Pregnant (potentially fertile patients must be not in pregnancy during and for at least 3 months after study participation and must have a negative serum pregnancy test)
- •Active infection requiring antibiotics
- •Symptomatic peripheral neuropathy > grade 2 according to the NCI Common Toxicity Criteria.
- •Congestive heart failure or angina pectoris even if it is medically controlled. Previous history of myocardial infarction within 1 year from study entry, uncontrolled high risk hypertension or arrhythmia.
- •Unstable or severe intercurrent medical condition that, in the opinion of the investigator, might interfere with achievement of study objectives
- •Psychological or sociological conditions, addictive disorders, or family problems, which would preclude compliance with the protocol
研究组 & 干预措施
Trabectedin
Trabectedin will be infused at the dose of 1.3 mg/m2 as a 3- hour iv infusion every 3 weeks via a central venous catheter.
干预措施: Trabectedin (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: three years
The primary endpoint of this study is to evaluate the activity of trabectedin in terms of the objective response rate (ORR) in patients with advanced uterine and ovarian carcinosarcoma.
次要结局
- Duration of response(three years)
- Overall Survival (OS)(three years)
- Adverse events(three years)
- Progression Free Survival (PFS)(three years)