Clinica trial of LEDC (Liposomal Encapsulated Doxorubicin Cytrate,Myocet®) + CARBOPLATIN IN EPITHELIAL ginecological CANCER

• Conditions: gynecological cancer; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2012-003173-25-ES
• Lead Sponsor: Dr. Andrés Poveda Velasco

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-02
• Last Update Posted: 17 December 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Phase I (Dose escalation)<br>To determine the maximum-tolerated dose (MTD) and recommended phase II dose of<br>the combination of Carboplatin + Myocet every three weeks<br>Phase II (Expansion)<br>To evaluate the activity (objective responses) of the combination of<br>Carboplatin+Myocet every 3weeks in patients with PS and PPS relapse.;Secondary Objective: To assess the toxicity of the combination Myocet+Carboplatin in PPS EOC patients.<br>To evaluate Pharmacokinetics<br>To assess PFS and OS;Primary end point(s): Incidence rate of DLT (First cycle) at every dose level (phase I)<br>? Objective response rate (ORR) according to RECIST 1.1 (phase II);Timepoint(s) of evaluation of this end point: Incidence rate of DLT (First cycle) at every dose level (phase I)<br>? Objective response rate (ORR) according to RECIST 1.1 (phase II)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): To assess the security of the combination: type of adverse events, frequency,<br>grade according to CTC v4.0.<br>? To evaluate the pharmacokinetics: plasma concentration of Carboplatin in<br>combination with Myocet and basic PK data.;Timepoint(s) of evaluation of this end point: To assess the security of the combination: type of adverse events, frequency,<br>grade according to CTC v4.0.<br>? To evaluate the pharmacokinetics: plasma concentration of Carboplatin in<br>combination with Myocet and basic PK data.