INOVATYON STUDY -International, Randomized Study in Patients With Ovarian Cancer
Conditions
Ovarian Cancer
Conditions: official terms
Ovarian Neoplasms
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Carboplatin Type: Drug
Name: Pegylated Lipoxomal Doxorubicin (PLD) Type: Drug
Name: Trabectedin Type: Drug
Overall Status
Recruiting
Summary
The objective of this multicentric, randomised, Phase III study is to demonstrate superiority, in terms of prolonged survival, of trabectedin and Pegylated Liposomal Doxorubicin (PLD) versus carboplatin and PLD.

Patients will be randomised to:

Arm A: PLD 30 mg/m2 and carboplatin AUC 5 Arm B: PLD 30 mg/m2 and trabectedin 1.1 mg/m2 Patients'/subjects' characteristics: patients over 18 years of age with advanced, progressive ovarian cancer 6-12 months after completion of first line treatment with platinum-based chemotherapy.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
Criteria: Inclusion Criteria:

1. Female, aged ≥ 18 years

2. Histologically and/or cytologically proven epithelial ovarian, epithelial fallopian tube cancer or primary peritoneal cancer

3. Progression free interval between six and twelve (6-12) months (calculated from the first day of the last cycle of the last platinum-based chemotherapy until the date of progression confirmation through radiologic imagery). Patients may have received up to two platinum-based chemotherapy lines, of which at least one must have contained a taxane

4. Measurable or evaluable disease confirmed by radiological imaging, such as magnetic resonance imaging (MRI), computed tomography (CT) scan, or PET/CT scan at study entry (CA-125 rise not supported by radiological evidence of disease is not accepted as criteria for defining progression) or histological proven recurrent ovarian cancer even in the absence of postoperatively measurable or evaluable lesions.

5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2

6. Estimated life expectancy ≥ 12 weeks

7. Patients must be accessible for treatment and follow-up

8. Adequate organ function within 14 days prior to first cycle as evidenced

9. Patients must be able to receive dexamethasone or its equivalent, which is required if randomly assigned to treatment with trabectedin plus PLD

10. Informed consent of the patient

Exclusion Criteria:

1. Non epithelial ovarian or mixed epithelial/non epithelial tumors (e.g., Mullerian tumors)

2. Patients who did not respond to last platinum-based therapy or in whom last relapse occurred < 6 months or > 12 months from the last dose of platinum

3. Bowel obstruction, sub-occlusive disease or the presence of symptomatic brain metastases

4. Pre-existing grade > 1 motor or sensory neuropathy according to the National Cancer Institute Common Toxicity Criteria Adverse Event (NCI-CTCAE) version 4.0

5. Myocardial infarct within six months before enrolment, New York Association (NYHA) Class II or worse heart failure (Appendix 1. The New York Heart Association), uncontrolled angina, severe uncontrolled ventricular arrythmias, clinically significant pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities

6. History of liver disease

7. Concurrent severe medical problems or any unstable medical condition unrelated to malignancy, which would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy

8. Breastfeeding women and women of child bearing potential must use effective contraception during treatment and 3 months thereafter, which may include prescription contraceptives (oral, injection, or patch), intrauterine device, double-barrier method or male partner sterilization (not applicable to patients that are surgically sterile)

9. Prior exposure to trabectedin

10. Prior resistance to anthracyclines or PLD defined as a progression during anthracycline-based chemotherapy or a recurrence within 6 months from its ending

11. Prior severe PLD related toxicity

12. Prior exposure to cumulative doses of doxorubicin >400mg/m2 or epirubicin >720mg/m2

13. Treatment with any investigational product within 30 days prior to inclusion in the study
Locations
Krankenhaus Der Barmherzigen Brueder
Graz, AT, Austria
Status: Recruiting
Contact: Christian Schauer
Univ. Clinic for Gynaecology and Obstetrics - Medical University of Innsbruck
Innsbruck, AT, Austria
Status: Not yet recruiting
Contact: Christian Marth
Imeldaziekenhuis
Bonheiden, BE, Belgium
Status: Not yet recruiting
Contact: Heidi Van den Bulck
AZ Klina
Brasschaat, BE, Belgium
Status: Not yet recruiting
Contact: Didier Verhoeven
Antwerp University Hospital
Edegem, BE, Belgium
Status: Not yet recruiting
Contact: Manon Huizing
UZ Leuven
Leuven, BE, Belgium
Status: Not yet recruiting
Contact: Ignace Vergote
CMSE Clinique et Maternité Sainte-Elisabeth
Namur, BE, Belgium
Status: Recruiting
Contact: Peter Vuylsteke
Az Damiaan
Oostende, BE, Belgium
Status: Not yet recruiting
Contact: Randal D'Hondt
Centrum Voor Oncologie
Turnhout, BE, Belgium
Status: Not yet recruiting
Contact: Gino Pelgrims
Centre Hospitalier Peltzer La Tourelle (CHPLT)
Verviers, BE, Belgium
Status: Not yet recruiting
Contact: Annelore Barbeaux
CHU Dinant Godinne / UCL Namur
Yvoir, BE, Belgium
Status: Not yet recruiting
Contact: Lionel D'Hondt
Odense University Hospital
Odense, DK, Denmark
Status: Not yet recruiting
Contact: Gitte-Bettina Nyvang
Tampere University Hospital
Tampere, FI, Finland
Status: Recruiting
Contact: Johanna Mäenpää - Johanna.Maenpaa@staff.uta.fi
Frauenklinik - Stadtspital Triemli
Zürich, CH, Germany
Status: Not yet recruiting
Contact: Heike Passmann
Charite Universitaetsmedizin
Berlin, DE, Germany
Status: Recruiting
Contact: Jalid Sehouli
Ev. Waldkrankenhaus Spandau
Berlin, DE, Germany
Status: Not yet recruiting
Contact: Jochem Potenberg
Praxis Dr. med. Jörg Schilling
Berlin, DE, Germany
Status: Not yet recruiting
Contact: Jörg Schilling
Praxisklinik Krebsheilkunde für Frauen
Berlin, DE, Germany
Status: Not yet recruiting
Contact: Gülten Oskay-Özcelik
Vivantes Netzwerk für Gesundheit GmbH
Berlin, DE, Germany
Status: Recruiting
Contact: Maike de Wit
University Hospital Dresden
Dresden, DE, Germany
Status: Recruiting
Contact: Pauline Wimberger
Dr. med. Georg Heinrich Schwerpunktpraxis für Gynäkologische Onkologie
Fürstenwalde, DE, Germany
Status: Recruiting
Contact: Georg Heinrich - g.heinrich@bngo.de
Kath. Marienkrankenhaus
Hamburg, DE, Germany
Status: Not yet recruiting
Contact: Gerhard Gebauer
Universitäts - Frauenklinik -Tübingen
Heidelberg, DE, Germany
Status: Recruiting
Contact: Eva-Maria Grischke - eva-maria.grischke@med.uni-tuebingen.de
Helios Klinikum Krefeld
Krefeld, DE, Germany
Status: Not yet recruiting
Contact: Michael Friedrich
"Universitätsklinikum Schleswig-Holstein
Lübeck, DE, Germany
Status: Not yet recruiting
Contact: Lars Christian Hanker
Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo
Alessandria, AL, Italy
Status: Not yet recruiting
Contact: Vittorio Fusco
Ospedale Regionale Umberto Parini
Aosta, AO, Italy
Status: Recruiting
Contact: Zuzana Sirotovà
"Ospedale Degli Infermi - Biella"
Biella, BI, Italy
Status: Recruiting
Contact: Laura Zavallone - laura.zavallone@libero.it
Policlinico S.Orsola Malpighi
Bologna, BO, Italy
Status: Not yet recruiting
Contact: Claudio Zamagni
P.O. "A.Perrino" ASL Brindisi
Brindisi, BR, Italy
Status: Not yet recruiting
Contact: Saverio Cinieri
A.O. Spedali Civili di Brescia
Brescia, BS, Italy
Status: Recruiting
Contact: Germana Tognon - germanatognon@alice.it
Fondazione Poliambulanza
Brescia, BS, Italy
Status: Recruiting
Contact: Alberto Zaniboni - alberto.zaniboni@poliambulanza.it
Azienda Ospedaliera S. Croce e Carle
Cuneo, CN, Italy
Status: Not yet recruiting
Contact: Gianna Di Costanzo
Ospedale Valduce
Como, CO, Italy
Status: Recruiting
Contact: Clelia Casartelli
Azienda Ospedaliero Universitaria "Policlinico- Vittorio Emanuele" P.O. Gaspare Rodolico
Catania, CT, Italy
Status: Not yet recruiting
Contact: Hèctor Soto Parra
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) - IRCCS, Meldola e Cesena
Meldola, FC, Italy
Status: Recruiting
Contact: Ugo De Giorgi - u.degiorgi@irst.emr.it
Ospedale San Giuseppe - Azienda USL11
Empoli, FI, Italy
Status: Not yet recruiting
Contact: Carlo Milandri
Ospedale SS Trinità - Sora
Sora, FR, Italy
Status: Recruiting
Contact: Teresa Gamucci
Ente Ospedaliero Ospedali Galliera
Genova, GE, Italy
Status: Recruiting
Contact: Andrea De Censi - andrea.decensi@galliera.it
IRCCS San Martino IST - Genova
Genova, GE, Italy
Status: Recruiting
Contact: Milena Bruzzone
AO della Provincia di Lecco - Ospedale Alessandro Manzoni
Lecco, LC, Italy
Status: Not yet recruiting
Contact: Antonio Ardizzoia
Ospedale Vito Fazzi
Lecce, LE, Italy
Status: Recruiting
Contact: Graziana Ronzino - gronzino@tiscali.it
European Institute of Oncology, Department of Surgery Science
Milan, MI, Italy
Status: Recruiting
Azienda Ospedaliero Universitaria Policlinico di Modena
Modena, MO, Italy
Status: Not yet recruiting
Contact: Roberto Sabbatini
AO Ospedali Riuniti Villa Sofia Cervello
Palermo, PA, Italy
Status: Not yet recruiting
Contact: Francesco Verderame
Ospedale Guglielmo da Saliceto - Piacenza
Piacenza, PC, Italy
Status: Recruiting
Contact: Luigi Cavanna - l.cavanna@ausl.pc.it
Istituto Oncologico Veneto
Padova, PD, Italy
Status: Recruiting
Contact: Mariaornella Nicoletto - mariaorn@libero.it
Ospedale Santa Chiara
Pisa, PI, Italy
Status: Recruiting
Contact: Angiolo Gadducci - a.gadducci@obgyn.med.unipi.it
Nuovo Ospedale di Prato S. Stefano
Prato, PO, Italy
Status: Recruiting
Contact: Elena Zafarana - ezafarana@usl4.toscana.it
Istituto di Ricovero e Cura a Carattere Scientifico - Centro Regionale Oncologico Basilicata
Rionero in Vulture, PZ, Italy
Status: Recruiting
Contact: Michele Aieta
Ospedale di Faenza
Faenza, RA, Italy
Status: Recruiting
Contact: Stefano Tamberi
Ospedale Umberto I
Lugo, RA, Italy
Status: Not yet recruiting
Contact: Maria Rosa Gentili
Azienda Ospedaliera "Bianchi - Melacrino - Morelli"
Reggio Calabria, RC, Italy
Status: Not yet recruiting
Contact: Roberto Maisano
IRCCS - Arcispedale S. Maria Nuova
Reggio Emilia, RE, Italy
Status: Recruiting
Contact: Alessandra Bologna - bologna.alessandra@asmn.re.it
Policlinico Umberto I, Universitàdi Roma "La Sapienza"
Roma, RM, Italy
Status: Recruiting
Contact: Enrico Cortesi - enrico.cortesi@uniroma1.it
Policlinico Umberto I, Universitàdi Roma "La Sapienza"
Roma, RM, Italy
Status: Recruiting
Contact: Piereluigi Benedetti Panici - pierluigi.benedettipanici@uniroma1.it
Ospedale Infermi
Rimini, RN, Italy
Status: Recruiting
Contact: Valentina Arcangeli - valentina.arcangeli@auslrn.net
Ospedale Civile di Sondrio
Sondrio, SO, Italy
Status: Recruiting
Contact: Alessandro Bertolini - alessandro.bertolini@aovv.it
Ospedale di Santa Chiara
Trento, TN, Italy
Status: Not yet recruiting
Contact: Viviana Murgia
Fondazione Piemontese Per L'Oncologia - IRCCS, Candiolo
Candiolo, TO, Italy
Status: Recruiting
Contact: Massimo Aglietta - massimo.aglietta@ircc.it
AOU Città della salute e della scienza - OIRM S. Anna
Torino, TO, Italy
Status: Recruiting
Contact: Paolo Zola - paolo.zola@unito.it
Azienda Ospedaliero Universitaria Città Della Salute e Della Scienza di Torino - P.O. S. Anna
Torino, TO, Italy
Status: Recruiting
Contact: Dionyssios Katsaros
Ospedale Mauriziano
Torino, TO, Italy
Status: Recruiting
Contact: Annamaria Ferrero
Ospedale Del Ponte - Varese
Varese, VA, Italy
Status: Recruiting
Contact: Nicoletta Donadello
U.L.S.S. 13 Mirano - Dolo - Noale
Mirano, VE, Italy
Status: Recruiting
Contact: Grazia Artioli - grazia.artioli@yahoo.it
Sacro Cuore Don Calabria
Negrar, VR, Italy
Status: Not yet recruiting
Contact: Stefania Gori
AOU Maggiore della Carità
Novara, Italy
Status: Not yet recruiting
Contact: Roberta Buosi
Radboud University Medical Centre
Nijmegen, NL, Netherlands
Status: Recruiting
Contact: Petronella Beatrix Ottevanger
Hospital General Universitario de Elche
Alicante, ES, Spain
Status: Not yet recruiting
Contact: Ana Beatriz Sanchez
Hospital Germans Trias I Pujol
Badalona, ES, Spain
Status: Recruiting
Contact: Margarita Romeo
Institut Català d´Oncologia, Hospitalet - Hospitalet de Llobregat
Barcellona, ES, Spain
Status: Recruiting
Contact: Beatriz Pardo Burdalo
Consorcio Hospitalario Provincial de Castellon
Castèllo, ES, Spain
Status: Recruiting
Contact: Angeles Lopez Rodriguez - angelalopez@comcas.es
Institut Català d'Oncologia de Girona
Girona, ES, Spain
Status: Recruiting
Contact: Pilar Barretina - mpbarretina@iconcologia.net
H. U. Arnau de Vilanova
Lleida, ES, Spain
Status: Recruiting
Contact: Eugenia Ortega
MD Anderson Cancer Center
Madrid, ES, Spain
Status: Recruiting
Contact: Antonio Gonzalez Martin
Althaia
Manresa, ES, Spain
Status: Not yet recruiting
Contact: Silvia Catot Tort
Hospital Universitario J.M. Morales Meseguer
Murcia, ES, Spain
Status: Recruiting
Contact: Elena Garcia Martinez - helenagarciam@gmail.com
Hospital Son Espases
Palma de Mallorca, ES, Spain
Status: Recruiting
Contact: Jesus Alarcon - jesus.alarcon@ssib.es
Hospital Son Llatzer
Palma de Mallorca, ES, Spain
Status: Recruiting
Contact: Isabel Bover - ibover@hsll.es
Complejo Hospitalario de Navarra
Pamplona, ES, Spain
Status: Not yet recruiting
Contact: Nuria Lainez Milagro
Corporacion Sanitaria y Universitaria Parc Tauli
Sabadell, ES, Spain
Status: Not yet recruiting
Contact: Yolanda Garcia Garcia
Hospital Universitario Donostia - San Sebastian
San Sebastian, ES, Spain
Status: Recruiting
Contact: Cristina Churruca Galaz Churruca Galaz - cristinamaria.churrucagalaz@osakidetza.net
Hospital General Universitario de Valencia
Valencia, ES, Spain
Status: Not yet recruiting
Contact: Cristina Caballero Diaz
Hospital La Fe
Valencia, ES, Spain
Status: Not yet recruiting
Contact: Ana Santaballa
IVO Instituto Valenciano de Oncologia
Valencia, ES, Spain
Status: Recruiting
Contact: Andres Poveda - apoveda@fivo.org
Kantonsspital Aarau
Aarau, CH, Switzerland
Status: Recruiting
Contact: Elena Kralidis - elena.kralidis@ksa.ch
Frauenklinik -Universitätsspital Basel
Basel, CH, Switzerland
Status: Recruiting
Contact: Viola Heinzelmann - viola.heinzelmann@usb.ch
Klinik Engeried
Bern, CH, Switzerland
Status: Not yet recruiting
Contact: Katharina Buser
Universitätsklinik für Frauenheilkunde, Universitätsklinik für Onkologische Medizin - Inselspital
Bern, CH, Switzerland
Status: Not yet recruiting
Contact: Michael Mueller
Kantonsspital Graubünden
Chur, CH, Switzerland
Status: Recruiting
Contact: Roger von Moos
Kantonsspital Frauenfeld
Frauenfeld, CH, Switzerland
Status: Recruiting
Contact: Mathias Fehr - mathias.fehr@stgag.ch
Luzerner Kantonsspital
Luzern, CH, Switzerland
Status: Not yet recruiting
Contact: Stefan Aebi
Kantonsspital Münsterlingen
Münsterlingen, CH, Switzerland
Status: Not yet recruiting
Contact: Christian Taverna
Kantonsspital Olten
Olten, CH, Switzerland
Status: Not yet recruiting
Contact: Catrina Uhlmann
Kantonsspital St. Gallen
St. Gallen, CH, Switzerland
Status: Recruiting
Contact: Salome Riniker - salome.riniker@kssg.ch
Kantonsspital
Winterthur, CH, Switzerland
Status: Not yet recruiting
Contact: Andreas Müller
Ospedale Regionale Bellinzona e Valli - Istituto Oncologico Della Svizzera Italiana (IOSI)
Bellinzona, TI, Switzerland
Status: Recruiting
Contact: Cristiana Sessa - Cristiana.Sessa@eoc.ch
Start Date
June 2011
Completion Date
December 2019
Sponsors
Mario Negri Institute for Pharmacological Research
Source
Mario Negri Institute for Pharmacological Research
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page