Overview

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