EUCTR2008-008746-20-AT进行中（未招募）不适用
Randomized Phase II AGO-Study comparing combined liposomal doxorubicin (Myocet) and gemcitabine (Gemzar) with liposomal doxorubicin (Myocet) monotherapy in platinum-refractory and platinum-resistant epithelial cancer of the ovary, fallopian tube, and the peritoneum - AGO 10
Studienzentrale AGO Austria0 个研究点目标入组 154 人开始时间: 2009年2月17日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 154
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •Histologically confirmed epithelial cancer of the ovary, the fallopian tube or the primary peritoneum.
- •Patients must have received first-line platinum-based chemotherapy.
- •Progression or recurrence during first-line platinum-based chemotherapy (= platinum-refractory disease) or progression/recurrence during the first 6 months following the end of the last platinum-containing chemotherapy (= day 21 or day 28) = platinum-resistant disease.
- •Age ? 18 years.
- •Karnofsky performance status > 70.
- •Life expectancy > 3 months.
- •Measurable metastatic disease on CT or MRI or ultrasound, or chest X-ray and/or
- •Evaluable disease on CT/MRI (e.g. ascites, pleural effusion) or chest X-ray (e.g. pleural effusion) and/or
- •Tumor marker progression (CA-125) according to the criteria by Rustin.
- •Increasing CA-125 levels according to Rustin et al. ( ):
- •CA-125 > 2x UNL (upper normal limit) or CA-125 > 2x nadir value on two occasions.
- •The date of progressive disease is defined as the first date of the CA-125 elevation to > 2x UNL or > 2x nadir value.
- •Normal organ functions:
- •?Adequate bone marrow function as indicated by:
- •?Platelets ? 100,000/mm3
- •?Hemoglobin > 10 g/dL
- •?Neutrophils > 1.5 x 103/mm3
- •?Adequate renal function as indicated by:
- •?Serum Creatinine <1.5 x the upper limit of normal
- •?Adequate liver function, as indicated by:
- •?Bilirubin < 1,5 x upper limit of normal (if no liver metastases are present)
- •?Bilirubin < 2,5 x upper limit of normal (if liver metastases are present)
- •?AST/ALT < 2.5 x upper limit of normal unless caused by parenchymal liver
- •Left ventricular ejection fraction of >50% in an echocardiography or MUGA Scan within 28 days of study start.
- •Written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients with childbearing capacity.
- •Ovarian carcinosarcoma (malignant mixed Müllerian tumor) or pure sarcoma.
- •Any known hypersensitivity to study drugs.
- •Previous chemotherapy with PEG-liposomal doxorubicin (Caelyx) or Gemzar®..
- •Significant comorbidity as e.g., uncontrolled infection, clinical signs of cardiac insufficiency, history of myocardial infarction or cardiac rhythmic disorders according to the NYHA classification LOWN > 2.
- •Any condition (medical, social, psychological), which would prevent adequate follow-up.
- •Active secondary malignant tumor diagnosed < 5 years (e.g. metastases from primary breast cancer).
研究者
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