Efficacy Study of Chemotherapy to Treat Ovarian Cancer Recurrence by Prolonging the Platinum Free Interval

• Status: Unknown status
• Trial end date: 2017-06-01
• Target enrollment: 0
• Participant gender: Female

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 ovarian cancer progression occurring 6-12 months after first-line treatment with a platinum-derivative.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute, Naples
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Doxorubicin; Gemcitabine; Liposomal doxorubicin; Paclitaxel; Topotecan

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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