Efficacy Study of Chemotherapy to Treat Ovarian Cancer Recurrence by Prolonging the Platinum Free Interval
Conditions
Ovarian Cancer
Conditions: official terms
Ovarian Neoplasms
Conditions: Keywords
platinum free interval, chemotherapy
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: stealth liposomal doxorubicin Type: Drug
Name: carboplatin Type: Drug
Name: paclitaxel Type: Drug
Name: Topotecan Type: Drug
Name: Gemcitabine Type: Drug
Overall Status
Recruiting
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.
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 chemotherapy for their recurrences, and the choice of chemotherapy depends largely on the time interval since the last therapy. Patients whose disease recurs longer than 12 months after a platinum containing treatment are considered to be platinum sensitive, and are candidates for retreatment with a platinum regimen.

Patients in whom disease recurs less than 6 months after a platinum containing treatment are considered platinum resistant or refractory, and are treated with a non platinum chemotherapy. The option of treatment is less clear for patients whose disease recurs between 6 and 12 months after platinum containing therapy. It is hypothesized that prolonging the interval since last platinum treatment by using a non platinum chemotherapy will result in better outcomes for these patients.

This study will evaluate if the experimental sequence of a non platinum based chemotherapy, followed at a later progression by a platinum based chemotherapy is superior, in terms of the effect on overall survival, to the standard inverse sequence of treatment.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: N/A
Gender: Female
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
Locations
AZ Groeninge
Kortrijk, Belgium
Status: Recruiting
UZ Gasthusiberg
Leuven, Belgium
Status: Recruiting
CHC-Clinique St-Joseph
Liège, Belgium
Status: Recruiting
Clinique & Maternité Sainte-Elisabeth
Namur, Belgium
Status: Recruiting
AZ Nikolaas
Sint Niklaas, Belgium
Status: Recruiting
Charité Campus Virchow-Klinkum
Berlin, Germany
Status: Active, not recruiting
Kliniken essen Mitte-Evang Huyssens Stiftung/Knappschaft
Essen, Germany
Status: Active, not recruiting
Universitatsklinikum
Essen, Germany
Status: Active, not recruiting
Universitatsklinikum
Freiburg, Germany
Status: Active, not recruiting
Gynecology, Albertinen Krankenhaus
Hamburg, Germany
Status: Active, not recruiting
Universitatskilinikum Schleswig-Holstein
Kiel, Germany
Status: Recruiting
Frauenklinik
Marburg, Germany
Status: Active, not recruiting
Klinikum rechts der Isar der Technischen Universitat
Munchen, Germany
Status: Active, not recruiting
Azienda Ospedaliera V. Cervello
Palermo, PA, Italy
Status: Recruiting
Ospedale S. Massimo, Day Hospital Oncologico
Penne, PE, Italy
Status: Recruiting
Centro di Riferimento Oncologico, Divisione di Oncolgia Medica C
Aviano, PN, Italy
Status: Recruiting
Ospedale Mazzoni
Ascoli Piceno, Italy
Status: Recruiting
Policlinico Universitario
Bari, Italy
Status: Recruiting
Universita di Bari Policinico I Clinical Ostetrica e Ginecologica
Bari, Italy
Status: Recruiting
Ospedale Fatebenefratelli
Benevento, Italy
Status: Recruiting
Ospedale Senatore Antonio Perrino
Brindisi, Italy
Status: Recruiting
Universita Cattolica del Sacro Cuore
Campobasso, Italy
Status: Recruiting
Ospedale Renzetti di Lanciano
Lanciano, Italy
Status: Recruiting
Ospedale A. Manzoni
Lecco, Italy
Status: Recruiting
Istituto Romagnolo per lo Studio e la Cura dei Tumori
Meldola, Italy
Status: Recruiting
Istituto Europeo di Oncologia
Milano, Italy
Status: Recruiting
Ospedale San Raffaele
Milano, Italy
Status: Recruiting
Ospedale S. Gerardo
Monza, Italy
Status: Recruiting
Istituto Nazionale dei Tumori , Oncologia Medica - Dipartimento Uro-Ginecologico
Napoli, Italy
Status: Recruiting
Ospedale Silvestrini
Perugia, Italy
Status: Recruiting
Ospedale Civile S. Spirito
Pescara, Italy
Status: Recruiting
A.O. Bianchi Melacrino Morelli Ospedale Riuniti
Reggio Calabria, Italy
Status: Recruiting
Arcispedale S. Maria Nuova
Reggio Emilia, Italy
Status: Recruiting
Ospedale degli Infermi, U.O. Oncologia Medica
Rimini, Italy
Status: Recruiting
Ospedale S. Giovanni Calibita Fatebenefratelli, UO di Oncologia
Roma, Italy
Status: Recruiting
Universita Cattolica del Sacro Cuore
Roma, Italy
Status: Recruiting
A.O. Ordine Mauriziano
Torino, Italy
Status: Recruiting
Ospedale S. Chiara
Trento, Italy
Status: Recruiting
A.O. di Udine S. Maria della Misericordia
Udine, Italy
Status: Recruiting
Ospedale Del Ponte
Varese, Italy
Status: Recruiting
Start Date
November 2008
Completion Date
December 2016
Sponsors
National Cancer Institute, Naples
Source
National Cancer Institute, Naples
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page