Clinical trial NCT00657878: Efficacy Study of Chemotherapy to Treat Ovarian Cancer Recurrence by Prolonging the Platinum Free Interval
Official title: Liposomal Doxorubicin Versus Carboplatin/Paclitaxel in Patients With Ovarian Cancer Recurrence Between 6 and 12 Months After Previous Platinum Based Therapy: Phase III Randomized Multicenter Study Amendment Title Protocol Version 2.0: Phase III International Multicenter Randomized Study Testing the Effect on Survival of Prolonging Platinum-free Interval in Patients With Ovarian Cancer Recurring Between 6 and 12 Months After Previous Platinum Based Chemotherapy.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Ovarian Cancer
Keywords: platinum free interval
chemotherapy
Lead sponsor: National Cancer Institute, Naples
Sponsor class: OTHER
First posted: 2008-04-14
Enrollment: 215
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: overall survival
timeFrame: 18 months
Secondary outcomes:
measure: progression free survival
timeFrame: 18 months
measure: changes in quality of life
timeFrame: 9 months
measure: number of objective responses
timeFrame: 6 months
measure: worst grade toxicity for each patient
timeFrame: 6 months
Other outcomes:
Locations:
city: Kortrijk
country: Belgium
facility: AZ Groeninge
city: Leuven
country: Belgium
facility: UZ Gasthusiberg
city: Liège
country: Belgium
facility: CHC-Clinique St-Joseph
city: Namur
country: Belgium
facility: Clinique & Maternité Sainte-Elisabeth
city: Sint Niklaas
country: Belgium
facility: AZ Nikolaas
city: Berlin
country: Germany
facility: Charité Campus Virchow-Klinkum
city: Essen
country: Germany
facility: Kliniken essen Mitte-Evang Huyssens Stiftung/Knappschaft
city: Essen
country: Germany
facility: Universitatsklinikum
city: Freiburg
country: Germany
facility: Universitatsklinikum
city: Hamburg
country: Germany
facility: Gynecology, Albertinen Krankenhaus
city: Kiel
country: Germany
facility: Universitatskilinikum Schleswig-Holstein
city: Marburg
country: Germany
facility: Frauenklinik
city: Munchen
country: Germany
facility: Klinikum rechts der Isar der Technischen Universitat
city: Palermo
country: Italy
facility: Azienda Ospedaliera V. Cervello
state: PA
city: Penne
country: Italy
facility: Ospedale S. Massimo, Day Hospital Oncologico
state: PE
city: Aviano
country: Italy
facility: Centro di Riferimento Oncologico, Divisione di Oncolgia Medica C
state: PN
city: Ascoli Piceno
country: Italy
facility: Ospedale Mazzoni
city: Bari
country: Italy
facility: Policlinico Universitario
city: Bari
country: Italy
facility: Universita di Bari Policinico I Clinical Ostetrica e Ginecologica
city: Benevento
country: Italy
facility: Ospedale Fatebenefratelli
city: Brindisi
country: Italy
facility: Ospedale Senatore Antonio Perrino
city: Campobasso
country: Italy
facility: Universita Cattolica del Sacro Cuore
city: Lanciano
country: Italy
facility: Ospedale Renzetti di Lanciano
city: Lecco
country: Italy
facility: Ospedale A. Manzoni
city: Meldola
country: Italy
facility: Istituto Romagnolo per lo Studio e la Cura dei Tumori
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia
city: Milano
country: Italy
facility: Ospedale San Raffaele
city: Monza
country: Italy
facility: Ospedale S. Gerardo
city: Napoli
country: Italy
facility: Istituto Nazionale dei Tumori , Oncologia Medica - Dipartimento Uro-Ginecologico
city: Perugia
country: Italy
facility: Ospedale Silvestrini
city: Pescara
country: Italy
facility: Ospedale Civile S. Spirito
city: Reggio Calabria
country: Italy
facility: A.O. Bianchi Melacrino Morelli Ospedale Riuniti
city: Reggio Emilia
country: Italy
facility: Arcispedale S. Maria Nuova
city: Rimini
country: Italy
facility: Ospedale degli Infermi, U.O. Oncologia Medica
city: Roma
country: Italy
facility: Ospedale S. Giovanni Calibita Fatebenefratelli, UO di Oncologia
city: Roma
country: Italy
facility: Universita Cattolica del Sacro Cuore
city: Torino
country: Italy
facility: A.O. Ordine Mauriziano
city: Trento
country: Italy
facility: Ospedale S. Chiara
city: Udine
country: Italy
facility: A.O. di Udine S. Maria della Misericordia
city: Varese
country: Italy
facility: Ospedale Del Ponte
Study officials:
affiliation: National Cancer Institute, Naples
name: Sandro Pignata, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: National Cancer Institute, Naples
name: Francesco Perrone, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: National Cancer Institute, Naples
name: Marilina Piccirillo, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Campania Luigi Vanvitelli
name: Ciro Gallo, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Piccirillo MC, Scambia G, Bologna A, Signoriello S, Vergote I, Baumann K, Lorusso D, Murgia V, Sorio R, Ferrandina G, Sacco C, Cormio G, Breda E, Cinieri S, Natale D, Mangili G, Pisano C, Cecere SC, Di Napoli M, Salutari V, Raspagliesi F, Arenare L, Bergamini A, Bryce J, Daniele G, Gallo C, Pignata S, Perrone F. Quality-of-life analysis of the MITO-8, MaNGO, BGOG-Ov1, AGO-Ovar2.16, ENGOT-Ov1, GCIG study comparing platinum-based versus non-platinum-based chemotherapy in patients with partially platinum-sensitive recurrent ovarian cancer. Ann Oncol. 2018 May 1;29(5):1189-1194. doi: 10.1093/annonc/mdy062.