Status:
UNKNOWN
Efficacy Study of Chemotherapy to Treat Ovarian Cancer Recurrence by Prolonging the Platinum Free Interval
Lead Sponsor:
National Cancer Institute, Naples
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
Phase:
PHASE3
Brief Summary
This study aims to test the hypothesis that the artificial prolongation of the platinum-free interval with a non-platinum treatment will improve the effectiveness of overall therapy in patients with o...
Detailed Description
Ovarian cancer is the most deadly gynecologic cancer. Though many patients respond well initially to chemotherapy, most of them in time will suffer a relapse. Patients often receive multiple lines of ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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 at least 3
- Previous treatment with stealth liposomal doxorubicin
- Residual peripheral neuropathy Grade 3 or higher
- 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 no greater than 1.25 x normal values) or liver function (ALT or AST no greater than 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
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2023
Estimated Enrollment :
215 Patients enrolled
Trial Details
Trial ID
NCT00657878
Start Date
November 1 2008
End Date
December 1 2023
Last Update
November 13 2023
Active Locations (40)
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1
AZ Groeninge
Kortrijk, Belgium
2
UZ Gasthusiberg
Leuven, Belgium
3
CHC-Clinique St-Joseph
Liège, Belgium
4
Clinique & Maternité Sainte-Elisabeth
Namur, Belgium