NCT00189410已完成2 期
Phase II Trial With Combination Chemotherapy Consisting of Pegylated Liposomal Doxorubicin (PLD) and Carboplatin in Malignant Gynecologic Tumour's
AGO Study Group38 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2003年6月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 38
- 主要终点
- Tolerance
研究概览
简要总结
Pegylated Liposomal Doxorubicin as well as Carboplatin have been showed efficacy in monotherapy as in combination therapy of gynaecologic tumours. As there is no common standard in the therapy of recurrent ovarian carcinoma, tumours of the uterus nor for non-epithelial ovarian tumours at time of designing of this study, this trial shall evaluate the new and well tolerated combination therapy consisting of Pegylated Liposomal Doxorubicin and Carboplatin.
详细描述
Aim of these study is the evaluation of combination chemotherapy in a patient subset with gynecologic tumours on regard to tolerance and efficacy.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed diagnosis of a gynecologic tumour [(non-epithelial ovarian tumour without germcell-tumours, tumours of the uterus (eg. Muellerian mixed tumours, Endometrial carcinomas, Uterus sarcoma, Cancer of the cervix)]
- •Target or non-target lesion. Patients with epithelial ovarian carcinoma are qualified also if they have a CA 125 increase only.
- •Patients with ovarian carcinoma must have completed a platin-containing chemotherapy more than 6 months at least. Patients with other malignancies could have prior chemotherapy, but must'nt
- •Prior Radiotherapy less than 25% of haemapoietic system is allowed, but should have completed at least 6 weeks prior or registration
- •Prior antitumoral hormone therapy, or specific immunotherapy is allowed, treatment have to be completed at least 3 weeks prior of registration
- •All women with childbearing potential have to be a negative pregnancy test within 7 days of registration
- •Perfomance Status 0-2 ECOG or more than 60% according to Karnofsky Index
- •Estimated expectancy of life of more than 12 weeks
- •adequate hematologic, renal and hepatic function according to following definitions: absolute Neutrophils >= 1,5 n/L Platelets >= 100 n/L Bilirubine <= 1,25 x ULN estimated glomerular filtration rate (Jelliffe) >= 60 ml/min
- •Patients who have given their signed and written informed consent to participate in the trial
- •Patients must be geographically accessible for treatment and follow
排除标准
- •More than 2 prior chemotherapies (or Radio-Chemotherapies)
- •active infection or concurrent severe medical problems unrelated to malignancy which would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy
- •application of other cytotoxic or antitumoral agents during study period
- •Patients with a history of seizure disorder or central nervous system disorders
- •History of congestive heart failure (NYHA Classification > 2, even if medically controlled.
- •History of clinical and electrocardiographically documented myocardial infarction within the last 6 months.
- •History of atrial or ventricular arrhythmias (> LOWN II)
- •Women who are pregnant or breast feeding
- •Fertile women not using adequate contraceptive measures
- •Patients who have used any investigational drugs within 30 days of study entry
结局指标
主要结局
Tolerance
Response Rate mainly in malignant uterine tumours
次要结局
- Time to Progression mainly in malignant uterine tumours
- Overall Survival mainly in malignant uterine tumours
研究者
研究点 (38)
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