Reintroduction of platinum-based therapy after treatment with trabectedin in patients with relapsed ovarian cancer resistant to platinum

Fundación para la investigación biomédica del Hospital Clínico San Carlos0 个研究点目标入组 12 人开始时间: 2015年1月26日最近更新: 2018年2月26日

试验速览

暂无简介。

•1. Histological or cytological diagnosis of epithelial carcinoma of the ovary, fallopian tube or primary peritoneal carcinoma.
•2. Pretreatment with carboplatin + paclitaxel, carboplatin or gemcitabine + carboplatin + liposomal doxorubicin.
•3. Resistance to treatment with platinum.
•4. Two or three lines of previous chemotherapy.
•6. ECOG PS 0-1
•7. Adequate bone marrow function:
•8. Creatinine clearance ? 30 ml / min, serum creatinine ? 1.5 mg / dL (? 132.6 mmol / l). Creatine phosphokinase (CPK) ? 2.5 x ULN
•10. Adequate hepatic function.
•11. Negative pregnancy test within 7 days prior to initiation of treatment.
•12. Women age: for the use of effective contraception during treatment and for 3 months thereafter.
•13. Informed consent of the patient.
•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 12
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Have received more than three prior chemotherapy lines.
•2. Prior exposure to trabectedin or hypersensitivity to any of the excipients
•3. Any severe or uncontrolled as, for example, uncontrolled systemic infection requiring therapy condition.
•4. Other prior malignancy treated within 5 years prior to enrollment in the study, except nonmelanoma skin carcinoma completely resected or in situ of the cervix or the cervix or basal cell skin carcinoma treated with curative intent .
•5. Any uncontrolled serious pre-existing medical or psychiatric condition and / or that could interfere with subject's safety, provision of informed consent or comply with study procedures.
•6. Metastatic brain or leptomeningeal disease.
•7. Treatment with any investigational product within 30 days prior to study entry.
•8. Pregnant or lactatiom
•9. significant chronic liver disease such as cirrhosis or active hepatitis

发起方

Fundación para la investigación biomédica del Hospital Clínico San Carlos