Doxorubicin hydrochloride for Recurrent ovarian cancer

Inclusion criteria

• {"criterion_text":"- Female aged ≥ 18 years\n- Histologically or cytologically documented invasive epithelial ovarian cancer, primary peritoneal carcinoma, or fallopian tube cancer\n- 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)\n- ECOG PS 0-1\n- 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)\n- Be able to receive IV dexamethasone or an equivalent IV corticosteroid\n- Have all of the following: -\themoglobin ≥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)\n- 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)\n- Have alkaline phosphatase (ALP) ≤ 2.5xULN; if the ALP is >2.5xULN, then an ALP liver fraction or 5' nucleotidase must be \n- Have AST and ALT ≤ 2.5xULN\n- Have LVEF by MUGA scan or 2D-ECHO within normal limits for the institution\n- Patients must be in postmenopausal (at least 12 months consecutive amenorrhea, in the appropriate age group and without other known or suspected cause), or have been sterilized surgically\n- Evidence of not pregnancy status as documented by a negative beta-human chorionic gonadotropin (ß-hCG) test\n- Not breastfeeding women\n- Adequate recovery from acute toxicity of any prior treatment"}

Exclusion criteria

• {"criterion_text":"- Non epithelial ovarian or mixed epithelial/non epithelial tumors (e.g., Mullerian tumors)\n- Patients who did not respond to last platinum-based therapy or in whom last relapse occurred < 6 months from the last dose of platinum\n- Bowel obstruction, sub-occlusive disease or the presence of symptomatic brain metastases\n- Known hypersensitivity to any of the components of PLD or trabectedin i.v. formulation\n- Previous treatment with Trabectedin\n- Known hypersensitivity to dexamethasone\n- Less than 4 weeks from last dose of therapy with any investigational agent, or chemotherapy.\n- History of another neoplastic disease (except basal cell carcinoma or cervical carcinoma in situ adequately treated) unless in remission for 3 years or longer\n- 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\n- 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\n- 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\n- Breastfeeding women\n- Pregnant women\n- Known clinically relevant CNS metastases\n- Psychiatric disorder that prevents compliance with protocol\n- Patients with concurrent serious or uncontrolled infection\n- Patients in need of yellow fever vaccine while on study chemotherapy\n- Active infection\n- Any other unstable medical condition"}

Primary endpoints

• {"endpoint_text":"- Response and progression will be evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1","definition_or_measurement_approach":"Evaluation according to RECIST version 1.1 (radiographic assessment of response and progression)"}

Other endpoints

• {"endpoint_text":"- Translational end point*: to define the correlation between genetic assessment, including BRCA1/2 genes, and Epithelial ovarian cancer (EOC) treatment and prognosis and to investigate how genetic pattern evolves over treatments\n- To analyze safety profile, progression free survival (PFS), overall survival (OS), following retreatment with trabectedin and PLD\n- To evaluate the time from enrollment to subsequent chemotherapy and the overall survival counted from the administration of subsequent chemotherapy\n- Duration of Response\n- Clinical benefit rate at 24 weeks\n- To evaluate serological response of CA-125\n- To analyze the quality of life (QoL) using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-C30 (QLQ-C30) and the Quality of Life Questionnaire-OV28 (QLQ-OV28)","definition_or_measurement_approach":"Translational: genetic assessment including BRCA1/2; Safety: analysis of adverse events; PFS/OS: standard time-to-event analyses; Time to subsequent chemotherapy and OS from subsequent chemotherapy: time-to-event; Duration of Response and Clinical Benefit Rate: response-based measures; CA-125 serological response: measurement of serum CA-125; QoL: EORTC QLQ-C30 and QLQ-OV28 questionnaires"}

Italy

Earliest CTIS Part Ii Submission Date

09-10-2024

Latest Decision Or Authorization Date

02-09-2025

Processing Time Days

328

Number Of Sites

13

Number Of Participants

64

Primary sponsor

Full Name

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy

Third parties

• {"country":"","full_name":"Pharma Mar S.A","duties_or_roles":"Source of monetary support","organisation_type":""}