Advanced ovarian cancer MedDRA version: 9.1 Level: LLT Classification code 10066697
Conditions
Interventions
Trade Name: YONDELIS*EV 1FL POLV 1MG
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Trabectedin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration
Sponsors
IST. DI RICERCHE FARMACOLOG. M. NEGRI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Female, aged = 18 years 2. Histologically and/or cytologically proven epithelial ovarian, epithelial fallopian tube cancer or primary peritoneal cancer 3. Progression free interval between six and twelve (6-12) months (calculated from the first day of the last cycle of the last platinum-based chemotherapy until the date of progression confirmation through radiologic imagery). Patients may have received up to two platinum-based chemotherapy lines, of which at least one must have contained a taxane 4. Measurable or evaluable disease confirmed by radiological imaging, such as magnetic resonance imaging (MRI), computed tomography (CT) scan, or PET/CT scan at study entry (CA-125 rise not supported by radiological evidence of disease is not accepted as criteria for defining progression) or histological proven recurrent ovarian cancer even in the absence of postoperatively measurable or evaluable lesions. 5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) = 2 6. Estimated life expectancy = 12 weeks 7. Patients must be accessible for treatment and follow-up 8. Adequate organ function within 14 days prior to first 9. Patients must be able to receive dexamethasone or its equivalent, which is required if randomly assigned to treatment with trabectedin plus PLD 10. Informed consent of the patient 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. Non epithelial ovarian or mixed epithelial/non epithelial tumors (e.g., Mullerian tumors) 2. Patients who did not respond to last platinum-based therapy or in whom last relapse occurred 12 months from the last dose of platinum 3. Bowel obstruction, sub-occlusive disease or the presence of symptomatic brain metastases 4. Pre-existing grade > 1 motor or sensory neuropathy according to the National Cancer Institute Common Toxicity Criteria Adverse Event (NCI-CTCAE) version 4.0 5. Myocardial infarct within six months before enrolment, New York Association (NYHA) Class II or worse heart failure (Appendix 1. The New York Heart Association), uncontrolled angina, severe uncontrolled ventricular arrythmias, clinically significant pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities 6. History of liver disease 7. 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 8. Breastfeeding women and women of child bearing potential must use effective contraception during treatment and 3 months thereafter, which may include prescription contraceptives (oral, injection, or patch), intrauterine device, double-barrier method or male partner sterilization (not applicable to patients that are surgically sterile) 9. Prior exposure to trabectedin 10. Prior resistance to anthracyclines or PLD defined as a progression during anthracycline-based chemotherapy or a recurrence within 6 months from its ending 11. Prior severe PLD related toxicity 12. Prior exposure to cumulative doses of doxorubicin >400mg/m2 or epirubicin >720mg/m2 13. Treatment with any investigational product within 30 days prior to inclusion in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that the combination of trabectedin (Yondelis) and pegylated liposomal doxorubicin (PLD) prolongs overall survival (OS) over carboplatin and PLD in patients with relapsed ovarian cancer progressing within 6-12 months after end of last platinum.;Secondary Objective: •To evaluate the time from randomization to subsequent chemotherapy and the overall survival counted from the administration of subsequent chemotherapy. •To evaluate serological response of CA-125 in each arm. •To compare the QoL in each arm using the EORTC Quality of Life •To compare safety profile, PFS, ORR, the type and length of remission (response rate and PFS) after subsequent therapies following each of the two combinations.;Primary end point(s): Overall-survival | — |
Countries
Austria, Belgium, Denmark, Finland, Germany, Italy, Netherlands, Norway, Spain, United Kingdom
Outcome results
None listed