Efficacy Study of Chemotherapy to Treat Ovarian Cancer Recurrence by Prolonging the Platinum Free Interval
NCT ID: NCT00657878
Last Updated: 2023-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
215 participants
INTERVENTIONAL
2008-11-30
2023-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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non platinum based chemotherapy
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
stealth liposomal doxorubicin
stealth liposomal doxorubicin 40 mg/m2 IV day 1 every 28 days
carboplatin
carboplatin AUC 5 IV day 1 every 21 days
paclitaxel
paclitaxel 175 mg/m2 IV day 1 every 21 days
Topotecan
dosing and schedule according to Institutional guidelines
Gemcitabine
1000 mg/m2 on days 1,8,15 every 28 days
platinum based chemotherapy
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
stealth liposomal doxorubicin
stealth liposomal doxorubicin 40 mg/m2 IV day 1 every 28 days
carboplatin
carboplatin AUC 5 IV day 1 every 21 days
paclitaxel
paclitaxel 175 mg/m2 IV day 1 every 21 days
Topotecan
dosing and schedule according to Institutional guidelines
Gemcitabine
1000 mg/m2 on days 1,8,15 every 28 days
Interventions
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stealth liposomal doxorubicin
stealth liposomal doxorubicin 40 mg/m2 IV day 1 every 28 days
carboplatin
carboplatin AUC 5 IV day 1 every 21 days
paclitaxel
paclitaxel 175 mg/m2 IV day 1 every 21 days
Topotecan
dosing and schedule according to Institutional guidelines
Gemcitabine
1000 mg/m2 on days 1,8,15 every 28 days
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
FEMALE
No
Sponsors
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National Cancer Institute, Naples
OTHER
Responsible Party
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Principal Investigators
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Sandro Pignata, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
National Cancer Institute, Naples
Francesco Perrone, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
National Cancer Institute, Naples
Marilina Piccirillo, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Cancer Institute, Naples
Ciro Gallo, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Campania Luigi Vanvitelli
Locations
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AZ Groeninge
Kortrijk, , Belgium
UZ Gasthusiberg
Leuven, , Belgium
CHC-Clinique St-Joseph
Liège, , Belgium
Clinique & Maternité Sainte-Elisabeth
Namur, , Belgium
AZ Nikolaas
Sint-Niklaas, , Belgium
Charité Campus Virchow-Klinkum
Berlin, , Germany
Kliniken essen Mitte-Evang Huyssens Stiftung/Knappschaft
Essen, , Germany
Universitatsklinikum
Essen, , Germany
Universitatsklinikum
Freiburg im Breisgau, , Germany
Gynecology, Albertinen Krankenhaus
Hamburg, , Germany
Universitatskilinikum Schleswig-Holstein
Kiel, , Germany
Frauenklinik
Marburg, , Germany
Klinikum rechts der Isar der Technischen Universitat
München, , Germany
Azienda Ospedaliera V. Cervello
Palermo, PA, Italy
Ospedale S. Massimo, Day Hospital Oncologico
Penne, PE, Italy
Centro di Riferimento Oncologico, Divisione di Oncolgia Medica C
Aviano, PN, Italy
Ospedale Mazzoni
Ascoli Piceno, , Italy
Policlinico Universitario
Bari, , Italy
Universita di Bari Policinico I Clinical Ostetrica e Ginecologica
Bari, , Italy
Ospedale Fatebenefratelli
Benevento, , Italy
Ospedale Senatore Antonio Perrino
Brindisi, , Italy
Universita Cattolica del Sacro Cuore
Campobasso, , Italy
Ospedale Renzetti di Lanciano
Lanciano, , Italy
Ospedale A. Manzoni
Lecco, , Italy
Istituto Romagnolo per lo Studio e la Cura dei Tumori
Meldola, , Italy
Istituto Europeo di Oncologia
Milan, , Italy
Ospedale San Raffaele
Milan, , Italy
Ospedale S. Gerardo
Monza, , Italy
Istituto Nazionale dei Tumori , Oncologia Medica - Dipartimento Uro-Ginecologico
Napoli, , Italy
Ospedale Silvestrini
Perugia, , Italy
Ospedale Civile S. Spirito
Pescara, , Italy
A.O. Bianchi Melacrino Morelli Ospedale Riuniti
Reggio Calabria, , Italy
Arcispedale S. Maria Nuova
Reggio Emilia, , Italy
Ospedale degli Infermi, U.O. Oncologia Medica
Rimini, , Italy
Ospedale S. Giovanni Calibita Fatebenefratelli, UO di Oncologia
Roma, , Italy
Universita Cattolica del Sacro Cuore
Roma, , Italy
A.O. Ordine Mauriziano
Torino, , Italy
Ospedale S. Chiara
Trento, , Italy
A.O. di Udine S. Maria della Misericordia
Udine, , Italy
Ospedale Del Ponte
Varese, , Italy
Countries
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References
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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.
Other Identifiers
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2008-001755-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MITO-8
Identifier Type: -
Identifier Source: org_study_id
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