Ovarian cancer MedDRA version: 22.0 Level: LLT Classification code 10026311 Term: Malignant neoplasm of ovary and other uterine adnexa System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10061535 Term: Ovarian neoplasm System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10061344 Term: Peritoneal neop
Conditions
Interventions
Trade Name: YONDELIS - 025 MG POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO- FLACONCINO (VETRO) 1 FLACONCINO
Product Name: Trabectedin
Product Code: [0]
Pharmaceutical Form: Co
Sponsors
FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE
Eligibility
Sex/Gender
All
Inclusion criteria
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 60 mL/min/1.73 m2 (Cockcroft-Gault) CPK 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, then an ALP liver fraction or 5' nucleotidase must be =65 years) yes F.1.3.1 Number of subjects for this age range 32
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that rechallenge with pegylated liposomal doxorubicin (PLD) with the combination of trabectedin (Yondelis®) is active (objective response rate) in relapsed ovarian cancer patients who have already received pegylated liposomal doxorubicin and progress within 6-12 months after the end of last platinum or in fully platinum sensitive patients not able to receive or not willing to receive other platinum treatments;Secondary Objective: • Traslational 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 • To analyze safety profile, progression free survival (PFS), overall survival (OS), following retreatment with trabectedin and PLD. • To evaluate the time from enrollment to subsequent chemotherapy and the overall survival counted from the administration of subsequent chemotherapy. • Duration of Response • Clinical benefit rate at 24 week • To evaluate serological response of CA-125. • 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) *Only selected centre will participate to this endpoint;Primary end point(s): Response and progression will be evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1;Timepoint(s) of evaluation of this end point: 24 months | — |
Countries
Italy
Contacts
Public ContactDirezione Scientifica Policlinico U
Direzione Scientifica Policlinico Universitario Agostino Gemelli IRCCS
Outcome results
None listed