epithelial ovarian carcinoma MedDRA version: 9.1 Level: PT Classification code 10061328
Conditions
Interventions
Trade Name: YONDELIS
Pharmaceutical Form: Powder for infusion*
INN or Proposed INN: Trabectedin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Trade Name: CAEL
Sponsors
UNIVERSITA` CAMPUS BIOMEDICO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years 2. Women diagnosed with instrumental (CT abdomen and pelvis) and / or serological (CA125> 35 U / ml) of relapse / progression of epithelial ovarian cancer .. 3. Patients should have executed at least one prior chemotherapy regimen 4. Availability to complete the protocol for the duration of the study 5. Acceptance of informed consent by the patient for each procedure in place that moves away of routes diagnostic and therapeutic standards, making it clear to the patient that any withdrawal from the experimental protocol, at any time, does not cause an impact on subsequent treatments to which will be submitted in future 6. Eastern Cooperative Oncology Group (ECOG) of 0 and 1. 7. Adequate blood counts: Hb> 9 g / dl, absolute number of neutrophils> 1500 l, 100,000 platelets per µl 8. Sensitive platinum, free interval with less than 6 months. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Prior exposure to trabectedin. 2. Patients who have not previously received any type of chemotherapy .. 3. Liver dysfunction, eg, bilirubin more than 1.5 times higher than normal levels, LDH, SGOT and SGPT doubled compared to normal or albumin 1.6 mg / dl 5. Widespread and uncontrolled systemic diseases other than cancer (chronic stable and well controlled like diabetes, high blood pressure do not constitute an exclusion criteria) 6. Treatment or concomitant diseases that could be confounding the results of the study, which preclude the completion of the protocol that could mask or adverse reactions. 7. Patients not hospitalized recently for complications from previous surgery or chemotherapy. In particular, patients should not have infectious events in progress. If progression occurred in the course of previous chemotherapy, waiting for the recruitment in the Protocol must be at least 4 weeks. 8. Patients unable to read or understand and / or unable to sign the necessary written consent before starting treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: TO EVALUATE THE EFFICACY OF TRABECTEDIN HOW SECOND -LINE DRUGS, IN COMBINATION WITH PLD IN PATIENTS WITH RELAPSED/PROGRESSION OF EPITHELIAL CARCINOMA OVARY;Secondary Objective: ASSESSING THE DEGREE OF TOXICITY TRABECTEDIN IN TERMS OF QUALITY OF LIFE IN PATIENTS WITH RECURRENCE / PROGRESSION OF EPITHELIAL CARCINOMA OVARY;Primary end point(s): evaluation of toxicity and quality of life in patients undergoing the treatment in question. | — |
Countries
Italy
Outcome results
None listed