EUCTR2012-003173-25-ES进行中（未招募）不适用
Clinica trial PHASE I-II of LEDC (Liposomal Encapsulated Doxorubicin Cytrate,Myocet®) + CARBOPLATIN IN EPITHELIAL ginecological CANCER
Dr. Andrés Poveda Velasco0 个研究点开始时间: 2012年10月2日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •Patients will participate in the clinical trial must meet each of the criteria described below:? Patients who have voluntarily signed informed consent before performing any test trial that is not part of routine care of patients.? Patients who do not have any condition (medical, social or psychological) that prevents compliance with the schedule of study visits and appropriate follow-up in the study.? Female patients aged less than 18 years.o Phase I:- Patients with ovarian cancer, endometrial, cervical, tubal or primary peritoneal.- Patients in progression and recurrence at least 2 treatment lines, and no active treatment option.or Phase II:- Patients with first, second or third recurrence of epithelial ovarian carcinoma or primary peritoneal tubal- Patients who have received a platinum-based regimen in the previous line of treatment before inclusion in the study.- Patients with relapsed platinum-sensitive (more than 12 months after the last administration of platinum) or- Patients with relapsing-partially platinum-sensitive (6-12 months after the last administration of platinum).? measurable disease according to the Criteria for Response Assessment in Solid Tumors (RECIST v1.1) confirmed clinically or radiologically, or non-measurable evaluable disease.? Prior radiation therapy for ? 25% of the hematopoietic system, at least 6 weeks before inclusion in the study.? Hormone interrupted during the 10 days prior to inclusion in the study.? Immunotherapy discontinued at least 4 weeks before inclusion in the study? ECOG Performance status ? 2.? Life expectancy ? 3 months.? Platelet count ? 100,000 ³? Hemoglobin ? 10 g / dl.? neutrophil count ? 1.5 x 10 ³ / mm ³.? Serum creatinine <1.5 times the upper limit of normal (ULN).? Bilirubin <1.5 times ULN.? AST / ALT <2.5 times ULN.? ejection fraction (LVEF) ? 50% measured by echocardiography or MUGA.? negative pregnancy test.
- •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 25
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Therapy prior pegylated liposomal doxorubicin or other anthracyclines. (Phase II).
- •? It supports previous anthracycline treatment if no response (Phase I).
- •? Known hypersensitivity to any of the study drugs.
- •? Evidence of other disease, metabolic dysfunction, physical examination finding or findings on clinical laboratory tests that create a reasonable suspicion that there is a condition or illness that precludes the use of any investigational drugs or put the patient in a high risk of treatment complications.
- •? Patients who are currently in another clinical trial or receiving any investigational agent within 30 days prior to their inclusion.
- •? History of other active neoplastic disease over the past 5 years.
- •? History of heart disease
- •? Active infection or other clinically severe infection.
研究者
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