advanced ovarian and uterine carcinosarcoma MedDRA version: 20.0 Level: LLT Classification code 10052204 Term: Ovarian carcinosarcoma System Organ Class: 100000004864 MedDRA version: 20.0 Level: LLT Classification code 10007508 Term: Carcinosarcoma uterus 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
Product Code: [YONDELIS]
Pharmaceutical Form:
Sponsors
FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Histologically documented Stage I-IV or recurrent uterine or ovarian carcinosarcoma not amenable to surgery or radiotherapy -No more than 2 previous chemotherapy lines -PS 0-2 (ECOG) -Age> 18 -Measurable disease -Life expectancy of at least 3 months -Adequate organ functions: a) Hematopoietic; Absolute neutrophil count = 1,500/mm^3; Platelet count = 100,000/mm^3; Hemoglobin = 9 g/dL b) Hepatic; AST and ALT = 1.5 times upper limit of normal (ULN)* ; Alkaline phosphatase = 2.5 times ULN* ; Bilirubin = 1.5 times ULN NOTE: * = 3 times ULN if liver metastases are present c) Renal; Creatinine Clearance = 45 mL/min or Serum Creatinine =1.5 x ULN d) Serum Albumin >3.0 g/dL -Previous Brachytherapy treatment for uterine carcinosarcoma is allowed -No other invasive malignancy within the past 3 years except non-melanoma skin cancer -Written Informed Consent 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 18
Exclusion criteria
Exclusion criteria: -More than 2 previous chemotherapy lines -Single tumor lesion inside a previous irradiated filed -Pregnant (potentially fertile patients must be not in pregnancy during and for at least 3 months after study participation and must have a negative serum pregnancy test) -Active infection requiring antibiotics -Symptomatic peripheral neuropathy > grade 2 according to the NCI Common Toxicity Criteria. -Congestive heart failure or angina pectoris even if it is medically controlled. Previous history of myocardial infarction within 1 year from study entry, uncontrolled high risk hypertension or arrhythmia. -Unstable or severe intercurrent medical condition that, in the opinion of the investigator, might interfere with achievement of study objectives -Psychological or sociological conditions, addictive disorders, or family problems, which would preclude compliance with the protocol
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety profile of trabectedin;Timepoint(s) of evaluation of this end point: Three years | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the activity in terms of objective response rate by RECIST version 1.1 (Complete and Partial Response [CR + PR]) with trabectedin in patients advanced uterine and ovarian carcinosarcoma;Secondary Objective: •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]. •Overall survival •Duration of response •Toxicity profile of trabectedin in this patient population ;Primary end point(s): The primary endpoint of this study is to evaluate the activity of trabectedin in terms of the objective response rate (ORR) in patients with advanced uterine and ovarian carcinosarcoma.;Timepoint(s) of evaluation of this end point: three years | — |
Countries
Italy
Contacts
Public ContactScientifica IRCCS Policlinico A. Ge
Direzione Scientifica IRCCS Policlinico A. Gemelli
Outcome results
None listed