Efficacy Study of Chemotherapy to Treat Ovarian Cancer Recurrence by Prolonging the Platinum Free Interval
- Conditions
- Ovarian Cancer
- Interventions
- Registration Number
- NCT00657878
- Lead Sponsor
- National Cancer Institute, Naples
- 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 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 215
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description platinum based chemotherapy stealth liposomal doxorubicin platinum based chemotherapy (corresponding to the combination of carboplatin + paclitaxel, or carboplatin + gemcitabine for patients with significant but lower than grade 3 neuropathy at baseline) followed by a non platinum based chemotherapy at disease progression non platinum based chemotherapy stealth liposomal doxorubicin a non platinum based therapy (corresponding to stealth liposomal doxorubicin, or topotecan, or gemcitabine,or any other drug approved in clinical practice for the treatment of patients with ovarian cancer after previous platinum-based chemotherapy) followed by a platinum based chemotherapy at disease progression non platinum based chemotherapy carboplatin a non platinum based therapy (corresponding to stealth liposomal doxorubicin, or topotecan, or gemcitabine,or any other drug approved in clinical practice for the treatment of patients with ovarian cancer after previous platinum-based chemotherapy) followed by a platinum based chemotherapy at disease progression non platinum based chemotherapy paclitaxel a non platinum based therapy (corresponding to stealth liposomal doxorubicin, or topotecan, or gemcitabine,or any other drug approved in clinical practice for the treatment of patients with ovarian cancer after previous platinum-based chemotherapy) followed by a platinum based chemotherapy at disease progression non platinum based chemotherapy Topotecan a non platinum based therapy (corresponding to stealth liposomal doxorubicin, or topotecan, or gemcitabine,or any other drug approved in clinical practice for the treatment of patients with ovarian cancer after previous platinum-based chemotherapy) followed by a platinum based chemotherapy at disease progression platinum based chemotherapy carboplatin platinum based chemotherapy (corresponding to the combination of carboplatin + paclitaxel, or carboplatin + gemcitabine for patients with significant but lower than grade 3 neuropathy at baseline) followed by a non platinum based chemotherapy at disease progression non platinum based chemotherapy Gemcitabine a non platinum based therapy (corresponding to stealth liposomal doxorubicin, or topotecan, or gemcitabine,or any other drug approved in clinical practice for the treatment of patients with ovarian cancer after previous platinum-based chemotherapy) followed by a platinum based chemotherapy at disease progression platinum based chemotherapy Topotecan platinum based chemotherapy (corresponding to the combination of carboplatin + paclitaxel, or carboplatin + gemcitabine for patients with significant but lower than grade 3 neuropathy at baseline) followed by a non platinum based chemotherapy at disease progression platinum based chemotherapy paclitaxel platinum based chemotherapy (corresponding to the combination of carboplatin + paclitaxel, or carboplatin + gemcitabine for patients with significant but lower than grade 3 neuropathy at baseline) followed by a non platinum based chemotherapy at disease progression platinum based chemotherapy Gemcitabine platinum based chemotherapy (corresponding to the combination of carboplatin + paclitaxel, or carboplatin + gemcitabine for patients with significant but lower than grade 3 neuropathy at baseline) followed by a non platinum based chemotherapy at disease progression
- Primary Outcome Measures
Name Time Method overall survival 18 months
- Secondary Outcome Measures
Name Time Method progression free survival 18 months changes in quality of life 9 months quality of life is measured at baseline and at 3 months and 6 months after patient begins study
worst grade toxicity for each patient 6 months number of objective responses 6 months
Trial Locations
- Locations (38)
Universita Cattolica del Sacro Cuore
🇮🇹Roma, Italy
Ospedale Mazzoni
🇮🇹Ascoli Piceno, Italy
Ospedale Senatore Antonio Perrino
🇮🇹Brindisi, Italy
Ospedale Renzetti di Lanciano
🇮🇹Lanciano, Italy
Ospedale S. Giovanni Calibita Fatebenefratelli, UO di Oncologia
🇮🇹Roma, Italy
UZ Gasthusiberg
🇧🇪Leuven, Belgium
Kliniken essen Mitte-Evang Huyssens Stiftung/Knappschaft
🇩🇪Essen, Germany
Ospedale Fatebenefratelli
🇮🇹Benevento, Italy
A.O. Ordine Mauriziano
🇮🇹Torino, Italy
Ospedale Del Ponte
🇮🇹Varese, Italy
Gynecology, Albertinen Krankenhaus
🇩🇪Hamburg, Germany
Universitatskilinikum Schleswig-Holstein
🇩🇪Kiel, Germany
Frauenklinik
🇩🇪Marburg, Germany
AZ Groeninge
🇧🇪Kortrijk, Belgium
AZ Nikolaas
🇧🇪Sint Niklaas, Belgium
CHC-Clinique St-Joseph
🇧🇪Liège, Belgium
Policlinico Universitario
🇮🇹Bari, Italy
Ospedale S. Massimo, Day Hospital Oncologico
🇮🇹Penne, PE, Italy
Azienda Ospedaliera V. Cervello
🇮🇹Palermo, PA, Italy
Arcispedale S. Maria Nuova
🇮🇹Reggio Emilia, Italy
Ospedale Civile S. Spirito
🇮🇹Pescara, Italy
Ospedale S. Chiara
🇮🇹Trento, Italy
A.O. Bianchi Melacrino Morelli Ospedale Riuniti
🇮🇹Reggio Calabria, Italy
Ospedale degli Infermi, U.O. Oncologia Medica
🇮🇹Rimini, Italy
A.O. di Udine S. Maria della Misericordia
🇮🇹Udine, Italy
Clinique & Maternité Sainte-Elisabeth
🇧🇪Namur, Belgium
Universitatsklinikum
🇩🇪Freiburg, Germany
Charité Campus Virchow-Klinkum
🇩🇪Berlin, Germany
Klinikum rechts der Isar der Technischen Universitat
🇩🇪Munchen, Germany
Centro di Riferimento Oncologico, Divisione di Oncolgia Medica C
🇮🇹Aviano, PN, Italy
Universita di Bari Policinico I Clinical Ostetrica e Ginecologica
🇮🇹Bari, Italy
Ospedale A. Manzoni
🇮🇹Lecco, Italy
Istituto Europeo di Oncologia
🇮🇹Milano, Italy
Ospedale San Raffaele
🇮🇹Milano, Italy
Istituto Romagnolo per lo Studio e la Cura dei Tumori
🇮🇹Meldola, Italy
Ospedale S. Gerardo
🇮🇹Monza, Italy
Istituto Nazionale dei Tumori , Oncologia Medica - Dipartimento Uro-Ginecologico
🇮🇹Napoli, Italy
Ospedale Silvestrini
🇮🇹Perugia, Italy