advaced ovarian cancer MedDRA version: 14.1 Level: HLT Classification code 10033129 Term: Ovarian neoplasms malignant (excl germ cell) System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: YONDELIS*EV 1FL POLV 1MG
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: TRABECTEDIN
CAS Number: 114899-77-3
Concentration unit: mg/m2 milligram(s)/square meter
Concentrati
Sponsors
POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with partially platinum sensitive ovarian cancer (platinum-free interval 6-12 months) who have previously received at least two platinum based chemotherapy lines, BRCA mutated or with BRCAness phenotype Definition of BRCAness phenotype: high-grade serous cancers, great initial sensitivity to platinum drugs and retention of platinum-sensitivity through multiple relapses, long history of disease, long survival, long TFIs between relapses (patients with high personal risk factors will be included after doing the analysis for BRCA 1-2 mutation before knowing the results). BRCA 1 and/or BRCA 2 mutation carriers (patients with established mutation will be included, patients with high personal risk factors will be included after doing the analysis before knowing the results) 2. Patients with platinum resistant ovarian cancer, BRCA mutated or with BRCAness phenotype who have previously received at least two previous chemotherapy lines (including platinum rechallenge)3. Patient’s written informed consent before any clinical trial-specific procedure. 4. 18 years-of-age or older. 5. Measurable disease as defined in the Response Evaluation Criteria in Solid Tumors (RECIST) Guidelines 6. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1. 7. Hematologic variables: a. Hemoglobin =9 g/dL b. Absolute neutrophil count (ANC) =1,500/µL, and c. Platelet count =100,000/µL. 8. Serum creatinine = 1.5 mg/dL or creatinine clearance = 30 mL/min 9. Creatinine phosphokinase (CPK) = 2.5 ULN. 10. Hepatic function variables a. Total bilirubin = ULN. b. Total alkaline phosphatase = 2.5 ULN c. AST (serum aspartate transaminase [SGOT]) and ALT (serum alanine transaminase [SGPT]) must be =2.5 x ULN. 11. Albumin = 25 g/l. 12. Adequately recovered from the acute toxicity of any prior treatment Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 67 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 33
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. More than two prior chemotherapy lines given in patients with resistant, BRCA mutated, ovarian cancer (including platinum rechallenge). 4. More than 3 prior chemotherapy lines given in patients with partially platinum sensitive, BRCA mutated and/or BRCAness phenotype ovarian cancer recurrences (including platinum rechallenge) 5. Less than 4 weeks from last dose of therapy with any investigational agent, or chemotherapy. 6. History of another neoplastic disease (except basal cell carcinoma or cervical carcinoma in situ adequately treated) unless in remission for 3 years or longer. 7. Known clinically relevant CNS metastases. 8. Other serious illnesses, such as: • Congestive heart failure or angina pectoris; myocardial infarction within 1 year before enrollment; uncontrolled arterial hypertension or arrhythmias • Psychiatric disorder that prevents compliance with protocol • Active viral hepatitis; or chronic liver disease • Active infection • Any other unstable medical conditions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the feasibility in terms of objective response rate by RECIST version 1.1 (Complete and Partial Response [CR + PR]) with trabectedin in patients with BRCA1 or BRCA2 mutation carrier or BRCAness phenotype advanced ovarian cancer patients.;Secondary Objective: • Duration of response. • Progression-free survival [the diagnosis of progression will be assessed by radiological criteria; CA 125 increases alone (GCIG criteria of progression) will not be considered as progression of disease without a radiological confirmation of progression]. • Safety profile of trabectedin in this patient population;Primary end point(s): Response rate;Timepoint(s) of evaluation of this end point: 63 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): duration of response PFS Safety;Timepoint(s) of evaluation of this end point: 63 days | — |
Countries
Italy
Contacts
Public ContactGinecologia oncologica
Istituto di ginecologia ed ostetricia
Outcome results
None listed