Pertuzumab in Platinum-Resistant Low Human Epidermal Growth Factor Receptor 3 (HER3) Messenger Ribonucleic Acid (mRNA) Epithelial Ovarian Cancer (PENELOPE)
NCT ID: NCT01684878
Last Updated: 2017-05-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
208 participants
INTERVENTIONAL
2012-10-22
2016-04-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Part 1: Pertuzumab + Topotecan
Participants received pertuzumab and topotecan in cycles of 3 weeks until progressive disease as per investigator's assessment, unacceptable toxicity, withdrawal of consent, or death.
Paclitaxel (Chemotherapy)
Participants administered paclitaxel at a dosage of 80 mg/m\^2 as 1 hour IV infusion on Days 1, 8 and 15 every 3 weeks.
Pertuzumab
Participants administered pertuzumab 840 milligrams (mg) IV infusion on Day 1 of the first treatment cycle as a loading dose, followed by 420 mg on Day 1 of each subsequent 3 weekly cycle.
Topotecan (Chemotherapy)
Participants administered topotecan at a dosage of 1.25 mg/m\^2 as a 30 minute IV infusion daily on Days 1 to 5 every 3 weeks.
Part 1: Pertuzumab + Paclitaxel
Participants received pertuzumab and paclitaxel in cycles of 3 weeks until progressive disease as per investigator's assessment, unacceptable toxicity, withdrawal of consent, or death.
Paclitaxel (Chemotherapy)
Participants administered paclitaxel at a dosage of 80 mg/m\^2 as 1 hour IV infusion on Days 1, 8 and 15 every 3 weeks.
Pertuzumab
Participants administered pertuzumab 840 milligrams (mg) IV infusion on Day 1 of the first treatment cycle as a loading dose, followed by 420 mg on Day 1 of each subsequent 3 weekly cycle.
Placebo
Participants administered pertuzumab matching placebo IV infusion on Day 1 of each 3 weekly cycle.
Part 2: Pertuzumab+Chemotherapy
Participants received pertuzumab and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigator's assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
Gemcitabine (Chemotherapy)
Participants administered gemcitabine at a dosage of 1000 milligrams per square meter (mg/m\^2) intravenous (IV) infusion on Days 1 and 8 every 3 weeks.
Paclitaxel (Chemotherapy)
Participants administered paclitaxel at a dosage of 80 mg/m\^2 as 1 hour IV infusion on Days 1, 8 and 15 every 3 weeks.
Pertuzumab
Participants administered pertuzumab 840 milligrams (mg) IV infusion on Day 1 of the first treatment cycle as a loading dose, followed by 420 mg on Day 1 of each subsequent 3 weekly cycle.
Topotecan (Chemotherapy)
Participants administered topotecan at a dosage of 1.25 mg/m\^2 as a 30 minute IV infusion daily on Days 1 to 5 every 3 weeks.
Part 2: Placebo+Chemotherapy
Participants received pertuzumab matching placebo and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigator's assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
Gemcitabine (Chemotherapy)
Participants administered gemcitabine at a dosage of 1000 milligrams per square meter (mg/m\^2) intravenous (IV) infusion on Days 1 and 8 every 3 weeks.
Paclitaxel (Chemotherapy)
Participants administered paclitaxel at a dosage of 80 mg/m\^2 as 1 hour IV infusion on Days 1, 8 and 15 every 3 weeks.
Placebo
Participants administered pertuzumab matching placebo IV infusion on Day 1 of each 3 weekly cycle.
Topotecan (Chemotherapy)
Participants administered topotecan at a dosage of 1.25 mg/m\^2 as a 30 minute IV infusion daily on Days 1 to 5 every 3 weeks.
Interventions
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Gemcitabine (Chemotherapy)
Participants administered gemcitabine at a dosage of 1000 milligrams per square meter (mg/m\^2) intravenous (IV) infusion on Days 1 and 8 every 3 weeks.
Paclitaxel (Chemotherapy)
Participants administered paclitaxel at a dosage of 80 mg/m\^2 as 1 hour IV infusion on Days 1, 8 and 15 every 3 weeks.
Pertuzumab
Participants administered pertuzumab 840 milligrams (mg) IV infusion on Day 1 of the first treatment cycle as a loading dose, followed by 420 mg on Day 1 of each subsequent 3 weekly cycle.
Placebo
Participants administered pertuzumab matching placebo IV infusion on Day 1 of each 3 weekly cycle.
Topotecan (Chemotherapy)
Participants administered topotecan at a dosage of 1.25 mg/m\^2 as a 30 minute IV infusion daily on Days 1 to 5 every 3 weeks.
Eligibility Criteria
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Inclusion Criteria
* Low Human epidermal growth factor receptor (HER) 3 messenger ribonucleic acid (mRNA) expression
* At least one measurable and/or non-measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version (V) 1.1
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
* Left ventricular ejection fraction (LVEF) greater than or equal to (\>/=) 50 percent (%)
* Negative serum pregnancy test in women of childbearing potential
* Women of childbearing potential must agree to use effective contraception as defined by protocol during and for at least 6 months post study treatment
Exclusion Criteria
* Ovarian tumors with low malignant potential (borderline tumors)
* History of other malignancy of prognostic relevance within the last 5 years, except for carcinoma in situ of the cervix or basal cell carcinoma, or tumors with a negligible risk for metastasis or death, such as adequately controlled basal-cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or carcinoma in situ of the breast
* Previous treatment with more than 2 chemotherapy regimens
* Any prior radiotherapy to the pelvis or abdomen
* History or evidence on physical/neurological examination of central nervous system disease unrelated to cancer (uncontrolled seizures), unless adequately treated with standard medical therapy
* Pre-existing peripheral neuropathy \>/= common toxicity criteria (CTC) grade 2 (applicable for paclitaxel cohort only)
* Inadequate organ function
* Uncontrolled hypertension or clinically significant cardiovascular disease
* Current known infection with human immunodeficiency virus (HIV) or active infection with hepatitis B virus (HBV), or hepatitis C virus (HCV)
* Current chronic daily treatment with corticosteroids (\>/= 10 mg per day of methylprednisolone or equivalent), excluding inhaled steroids
* History of receiving any investigational treatment within 28 days prior to first study drug administration
* For Part 2 of the trial: prior enrollment into Part 1 of the trial
* Concurrent participation in any therapeutic clinical trial
18 Years
FEMALE
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Tiroler Landeskrankenanstalten Ges.M.B.H.; Abt. Für Gynäkologie
Innsbruck, , Austria
Medizinische Universität Wien; Univ.Klinik für Frauenheilkunde - Klinik für Gynäkologie
Vienna, , Austria
UZ Leuven Gasthuisberg
Leuven, , Belgium
Herlev Hospital; Onkologisk afdeling
Herlev, , Denmark
Rigshospitalet, Onkologisk Klinik
København Ø, , Denmark
Institut Bergonie; Oncologie
Bordeaux, , France
Centre Francois Baclesse; Oncologie
Caen, , France
Centre Georges Francois Leclerc; Oncologie 3
Dijon, , France
CRLCC Val dAurelle Paul Lam
Montpellier, , France
Hopital Tenon; Oncologie Radiotherapie
Paris, , France
Ch Lyon Sud; Chir Onc Gyne Sct Jules Courmont
Pierre-Bénite, , France
Clinique Armoricaine Radiologie; Hopital de Jour
Plérin, , France
Ico Rene Gauducheau; Oncologie
Saint-Herblain, , France
Centre Alexis Vautrin; Oncologie Medicale
Vandœuvre-lès-Nancy, , France
Institut Gustave Roussy; Oncologie Medicale
Villejuif, , France
St. Elisabeth Krankenhaus Köln GmbH; Gynäkologie und Geburtshilfe
Cologne, , Germany
Universitätsklinikum "Carl Gustav Carus"; Frauenheilkunde und Geburtshilfe
Dresden, , Germany
Evangelischen Krankenhauses Düsseldorf; Frauenklinik
Düsseldorf, , Germany
Universitätsklinikum Essen; Zentrum Für Frauenheilkunde
Essen, , Germany
Kliniken Essen-Mitte Evang. Huyssens-Stiftung, Klinik für Gynäkologie und gynäkologische Onkologie
Essen, , Germany
Universitätsklinikum Freiburg; Frauenklinik
Freiburg im Breisgau, , Germany
Universitätsklinikum Greifswald; Klinik für Frauenheilkunde und Brustzentrum
Greifswald, , Germany
Universitätsklinikum Hamburg-Eppendorf (UKE); Klinik und Poliklinik für Gynäkologie
Hamburg, , Germany
Gynaekologisch-Onkologische Schwerpunktpraxis Prof. Dr. med. Lueck, Dr. Schrader und Dr. Noeding
Hanover, , Germany
Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg
Heidelberg, , Germany
UNI-Klinikum Campus Kiel Klinik f.Gynäkologie u.Geburtshilfe
Kiel, , Germany
Klinikum Konstanz, Frauenklinik
Konstanz, , Germany
Klinikum rechts der Isar der TU München; Frauenklinik & Poliklinik
München, , Germany
Sana Klinikum Offenbach GmbH; Klinik für Gynäkologie & Geburtshilfe
Offenbach, , Germany
Hämatologisch/Onkologische Praxis Dr. Herbrick - Zipp/Prof. Dr. Decker, Studienzentrum
Ravensburg, , Germany
Universitätsfrauen- und Poliklinik am Klinikum Suedstadt
Rostock, , Germany
Universitätsklinik Tübingen; Frauenklinik
Tübingen, , Germany
Universitätsklinikum Ulm Am Michelsberg; Frauenklinik
Ulm, , Germany
HELIOS Dr. Horst Schmidt Kliniken Wiesbaden; Klinik für Gynäkologie und gynäkologische Onkologie
Wiesbaden, , Germany
Istituto Tumori Napoli;Unità Operativa Oncologia Medica Uro-Ginecologica
Napoli, Campania, Italy
Istituto Regina Elena; Oncologia Medica A
Rome, Lazio, Italy
Ente Ospedaliero Ospedali Galliera; S.C. Oncologia Medica
Genoa, Liguria, Italy
A.O.Spedali Civili; Ostetricia e Ginecologia
Brescia, Lombardy, Italy
Istituto Nazionale dei Tumori; Divisione Oncologia Chirurgica e Ginecologica
Milan, Lombardy, Italy
Istituto Europeo Di Oncologia
Milan, Lombardy, Italy
A.O.U Pisana; Dipartimento di Ginecologia Oncologica
Pisa, Tuscany, Italy
Antoni van Leeuwenhoek Ziekenhuis
Amsterdam, , Netherlands
Academ Ziekenhuis Groningen; Medical Oncology
Groningen, , Netherlands
Academisch Ziekenhuis Leiden; Clinical Oncology
Leiden, , Netherlands
UMC St Radboud
Nijmegen, , Netherlands
The Norvegian Radium Hospital Montebello; Dept of Oncology
Oslo, , Norway
Hospital Son Llatzer; Servicio de Oncologia
Palma de Mallorca, Balearic Islands, Spain
Hospital Univ Vall d'Hebron; Servicio de Oncologia
Barcelona, Barcelona, Spain
Hospital Clínic i Provincial; Servicio de Hematología y Oncología
Barcelona, Barcelona, Spain
Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
Barcelona, Barcelona, Spain
Hospital Duran i Reynals; Oncologia
Barcelona, Barcelona, Spain
Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
Barcelona, Barcelona, Spain
Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
Sabadell, Barcelona, Spain
Hospital Universitario Reina Sofia; Servicio de Oncologia
Córdoba, Cordoba, Spain
Hospital Universitari de Girona Dr. Josep Trueta; Servicio de Oncologia
Girona, Girona, Spain
Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Oncologia
Lleida, Lerida, Spain
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
Madrid, Madrid, Spain
Centro Oncologico MD Anderson Internacional; Servicio de Oncologia
Madrid, Madrid, Spain
Hospital Universitario 12 de Octubre; Servicio de Oncologia
Madrid, Madrid, Spain
Hospital Universitario La Paz; Servicio de Oncologia
Madrid, Madrid, Spain
Centro Integral Oncologico Clara Campal (CIOCC); Dirección Médica
Madrid, Madrid, Spain
Hospital Regional Universitario Carlos Haya; Servicio de Oncologia
Málaga, Malaga, Spain
Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia
Murcia, Murcia, Spain
Instituto Valenciano Oncologia; Oncologia Medica
Valencia, Valencia, Spain
Hospital Universitario la Fe; Servicio de Oncologia
Valencia, Valencia, Spain
Hospital Universitario Miguel Servet; Servicio Oncologia
Zaragoza, Zaragoza, Spain
Universitetssjukhuset; Onkologkliniken
Linköping, , Sweden
Skånes University Hospital, Skånes Department of Onclology
Lund, , Sweden
Countries
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References
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Lorusso D, Hilpert F, Gonzalez Martin A, Rau J, Ottevanger P, Greimel E, Luck HJ, Selle F, Colombo N, Kroep JR, Mirza MR, Berger R, Pardo B, Grischke EM, Berton-Rigaud D, Martinez-Garcia J, Vergote I, Redondo A, Cardona A, Bastiere-Truchot L, du Bois A, Kurzeder C; PENELOPE trial investigators. Patient-reported outcomes and final overall survival results from the randomized phase 3 PENELOPE trial evaluating pertuzumab in low tumor human epidermal growth factor receptor 3 (HER3) mRNA-expressing platinum-resistant ovarian cancer. Int J Gynecol Cancer. 2019 Sep;29(7):1141-1147. doi: 10.1136/ijgc-2019-000370. Epub 2019 Aug 15.
Other Identifiers
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2011-005975-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MO28113
Identifier Type: -
Identifier Source: org_study_id
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