STEALTH LIPOSOMAL DOXORUBICIN vs CARBOPLATIN/PACLITAXEL IN PATIENTS WITH OVARIAN CANCER RECURRENCE BETWEEN SIX AND TWELVE MONTHS AFTER PREVIOUS PLATINUM BASED CHEMOTHERAPY: PHASE III MULTICENTER RANDOMIZED STUDY - MITO-8
- Conditions
- OVARIAN CANCER RECURRENCEMedDRA version: 9.1Level: LLTClassification code 10066697Term: Ovarian cancer recurrent
- Registration Number
- EUCTR2008-001755-22-IT
- Lead Sponsor
- ISTITUTO NAZIONALE PER LO STUDIO E LA CURA DEI TUMORI - FONDAZIONE G. PASCALE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- 250
Histological or cytological diagnosis of ovarian cancer
Disease recurrence between 6 and 12 months after a first-line platinum based therapy
Indication for chemotherapy, but no more than 2 previous lines of previous therapy
Life expectancy of more than 3 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
Previous or concomitant malignant malignancy (excluding adequately treated baso-or squamocellular carcinoma of the skin and carcinoma in situ of the cervix)
ECOG Performance Status ³ 3
Previous treatment with stealth liposomal doxorubicin
Residual peripheral neuropathy > Grade 2
Heart disease (congestive heart failure, myocardial infarction within 6 months from study entry, atrioventricular block of any grade, severe arrhythmias)
Neutrophils < 2000 x mm3, platelets < 100000 x mm3
Inadequate renal function (creatinine ³ 1.25 x normal values) or liver function (ALT or AST ³ 1.25 x normal values)
Present or suspected hemorrhagic syndromes
Inability to comply with protocol and follow-up
Inability to access study site for clinical visits
Refusal of informed consent
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method