RECHALLENGE WITH PEGYLATED LIPOSOMAL DOXORUBICIN ADDED TO TRABECTEDIN IN RECURRENT OVARIAN CANCER: A MULTICENTER, PROSPECTIVE TRIAL (REPRAB study – MITO 36)

Phase 1

• Conditions: Ovarian cancer; MedDRA version: 22.0Level: LLTClassification code 10026311Term: Malignant neoplasm of ovary and other uterine adnexaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10061535Term: Ovarian neoplasmSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10061344Term: Peritoneal neoplasmSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-004690-14-IT
• Lead Sponsor: FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-24
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 64

Inclusion Criteria

• Female aged = 18 years
• Histologically or cytologically documented invasive epithelial ovarian cancer, primary peritoneal carcinoma, or fallopian tube cancer
• Partially platinum sensitive patients or fully platinum sensitive patients not able to receive or not willing to receive other platinum treatments, who have previously received PLD(carboplatin-pegylated liposomal doxorubicin or pegylated liposomal doxorubicin alone).
• ECOG PS 0-1.
• Subject has radiographically-documented measurable disease, as per RECIST 1.1 at study entry (CA-125 rise not supported by radiological evidence of disease is not accepted as criteria for defining progression).
• Be able to receive IV dexamethasone or an equivalent IV corticosteroid.
• Have all of the following: hemoglobin =9 g/dL (without transfusion in the prior 7 days).
Subjects may be enrolled into the study while receiving recombinant erythropoietin provided they have received recombinant erythropoietin for at least 4 weeks before the first dose of study drug. albumin >25 g/L absolute neutrophil count (ANC) >1,500/µL platelet count >100,000/µL (without transfusion in the prior 7 days) either a serum creatinine <=1.5 mg/dL or a calculated glomerular filtration rate
>60 mL/min/1.73 m2 (Cockcroft-Gault) CPK <2.5 x upper limit of normal (ULN)
• Have total bilirubin 1,5xULN, measure direct and indirect bilirubin to evaluate for Gilbert’s syndrome (if direct bilirubin is within normal range, subject may be eligible).
• Have alkaline phosphatase (ALP) <=2.5xULN; if the ALP is >2.5xULN, then an ALP liver
fraction or 5' nucleotidase must be • Have AST and ALT <=2.5xULN.
• Have LVEF by MUGA scan or 2D-ECHO within normal limits for the institution.
• Patients with child-bearing potential using (or willing to use) effective contraception during treatment and 3 months ahead unless they are postmenopausal (at least 12 months consecutive amenorrhea, in the appropriate age group and without other known or suspected cause), or have been sterilized surgically
• Evidence of not pregnancy status as documented by a negative beta-human chorionic gonadotropin (ß-hCG) test
• Not breastfeeding women
• Adequate recovery from acute toxicity of any prior treatment
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 32
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 32

Exclusion Criteria

• Non epithelial ovarian or mixed epithelial/non epithelial tumors (e.g., Mullerian tumors)
• Patients who did not respond to last platinum-based therapy or in whom last relapse occurred < 6 months from the last dose of platinum
• Bowel obstruction, sub-occlusive disease or the presence of symptomatic brain metastases
• Known hypersensitivity to any of the components of PLD or trabectedin i.v. formulation
• Previous treatment with Trabectedin
• Known hypersensitivity to dexamethasone
• Less than 4 weeks from last dose of therapy with any investigational agent, or chemotherapy.
• History of another neoplastic disease (except basal cell carcinoma or cervical carcinoma in situ adequately treated) unless in remission for 3 years or longer
• Myocardial failure within six months before enrolment, New York Heart Association (NYHA) Class II or worse heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, clinically significant pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities
• Known significant chronic liver disease, such as cirrhosis or active hepatitis (potential subjects who test positive for hepatitis B surface antigen or hepatitis C antibodies are allowed provided they do not have active disease requiring antiviral therapy). Also known history of liver carcinoma and cholangitis with abnormal liver functionality
• Concurrent severe medical problems or any unstable medical condition unrelated to malignancy, which would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy
• Breastfeeding women
• Pregnant women
• Known clinically relevant CNS metastases
• Psychiatric disorder that prevents compliance with protocol
• Patients with concurrent serious or uncontrolled infection
• Patients in need of yellow fever vaccine while on study chemotherapy
• Active infection
• Any other unstable medical condition

Study & Design

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