ovarian cancer MedDRA version: 20.0 Level: LLT Classification code 10051938 Term: Ovarian adenocarcinoma System Organ Class: 100000004864
Conditions
Interventions
Trade Name: YONDELIS - 1 MG POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO (VETRO) 1 FLACONCINO
Product Name: Yondelis
Pharmaceutical Form: Powder for solution for i
Sponsors
FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with partially platinum sensitive ovarian cancer (platinum-free interval 6-12 months) who have not received first line treatment. 2. 18 years of age of older 3. Patient’s written informed consent before any clinical trial specific procedures 4. Measurable disease according to RECIST criteria 5. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1 6. Hematologic variables: • Hemoglobin = 9 g/dL • Absolute Neutrophils count (ANC) =1,500/µL • Platelets count =100,000/µL • Serum Creatinine = 1.5 mg/dL or Creatinine Clearance = 30 mL/min • Creatinine Phosphokinase (CPK) = 2.5 ULN • Hepatic function variables • Total Bilirubin = ULN. • Total Alkaline Phosphatase = 2.5 ULN • AST (serum aspartate transaminase [SGOT]) must be = 2.5 x ULN • ALT (serum alanine transaminase [SGPT]) must be = 2.5 x ULN • Albumin = 25 g/l. 7. Recovery from toxic effects of prior therapies to NCI CTC Grade 1 or lower 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) yes F.1.3.1 Number of subjects for this age range 14
Exclusion criteria
Exclusion criteria: 1. Prior exposure to trabectedin 2. Known hypersensitivity to any of the components of the trabectedin i.v. formulation or dexamethasone 3. Less than 4 weeks from last dose of therapy with any investigational agent, or chemotherapy 4. History of another neoplastic disease (except basal cell carcinoma or cervical carcinoma in situ adequately treated) unless in remission for 3 years or longer 5. Known clinically relevant CNS metastases 6. Other serious illnesses, such as: congestive heart failure or angina pectoris; myocardial infarction within 1 year before enrollment; uncontrolled arterial hypertension or arrhythmias. 7. Psychiatric disorder that prevents compliance with protocol. 8. Active viral hepatitis; or chronic liver disease. 9. Active infection. 10. Any other unstable medical conditions.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Duration of response ¿ Progression-free survival ¿ Safety profile of trabectedin and Quality of Life (QoL) evaluation by EORTC-OV-28 questionnaire. ;Timepoint(s) of evaluation of this end point: 36 mesi | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of efficacy of single agent trabectedin in first line treatment in partially platinum-senstive recurrent ovarian cancer.;Secondary Objective: Duration of response ¿ Progression-free survival ¿ Safety profile of trabectedin and Quality of Life (QoL) evaluation by EORTC-OV-28 questionnaire. ;Primary end point(s): evaluation of objective response rate to trabectedin by Response Evaluation Criteria in Solid Tumor (RECIST) (version 1.1) in recurrent partially platinum sensitive ovarian cancer patients;Timepoint(s) of evaluation of this end point: 36 months | — |
Countries
Italy
Contacts
Public ContactUOC GINECOLOGIA ONCOLOGICA
POLICLINICO GEMELLI
Outcome results
None listed