Randomized Study of Paclitaxel-carboplatin Followed by Niraparib Compared to Paclitaxel-carboplatin-bevacizumab Followed by Niraparib+bevacizumab in Patients with Advanced Ovarian Cancer, Following a Front-line Complete Surgery

Who is this study for? Patients with Ovarian Cancer
What treatments are being studied? Chemotherapy+Niraparib
Status: Recruiting
Location: See all (87) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Randomized, open label, phase II multicenter study to assess the efficacy niraparib versus niraparib +bevacizumab maintenance in patients with newly diagnosed stage IIIA/B/C high-grade epithelial ovarian cancer with no residual disease after frontline surgery and treatment by adjuvant platinum-basedchemotherapy +/-bevacizumab.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

• For inclusion in the study, patient should fulfill the following criteria:

• Female patient ≥ 18 years of age.

• Signed informed consent and ability to comply with treatment and follow-up.

• Patient with newly diagnosed, a. Ovarian cancer, primary peritoneal cancer and/or fallopian-tube cancer, b. Histologically confirmed (based on local histopathological findings):

• • high grade serous or

⁃ high grade endometrioid (grade 2 and 3) or

⁃ other epithelial non mucinous and non-clear cell ovarian cancer in a patient with germline BRCA 1 or 2 deleterious mutation, c. At an advanced stage: FIGO stage IIIA to IIIC of the 2018 FIGO classification.

• Patient having undergone frontline, complete cytoreductive surgery (i.e. no visible residual disease): The patient will be considered eligible once the ESGO Quality Assurance in Ovarian Cancer Surgery will have been filled out and validated

• Eastern Cooperative Oncology Group (ECOG) performance status 0-1.

• Patient must have received one cycle of carboplatin AUC 5-6 + paclitaxel 175 mg/m²

• Patient must have started cycle 1 chemotherapy no later than 6 weeks after surgery.

• Patient must have a thorax-abdomen-pelvis CT scan between surgery and Cycle 1, with no evidence of disease.

• Patient eligible for first line platinum-taxane chemotherapy:

⁃ Patient eligible for bevacizumab treatment in combination with chemotherapy and in maintenance. It must be started at the second chemotherapy cycle and be administered at a dose of 15mg/kg every 3 weeks up to a total of 15 months.

⁃ Patient must have normal organ and bone marrow function before first cycle of chemotherapy:

∙ Hemoglobin ≥ 9.0 g/dL.

‣ Absolute neutrophil count (ANC) ≥ 1.5 x 109/L.

‣ Platelet count ≥ 100 x 109/L.

‣ Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN).

‣ Aspartate aminotransferase/Serum Glutamic Oxaloacetic Transaminase (ASAT/SGOT)) and Alanine aminotransferase /Serum Glutamic Pyruvate Transaminase (ALAT/SGPT)) ≤ 2.5 x ULN.

‣ Serum creatinine ≤ 1. 5 x institutional ULN and GFR \> 50 mL/min, by using an exact measure (ie. Iohexol clearance) or the most appropriate formula (Jeliffe, Cockroft Gault, MDRD, CKD-EPI) to the investigator's discretion.

‣ Patient not receiving anticoagulant medication who has an International Normalized Ratio (INR) ≥1.5 and an Activated ProThrombin Time (aPTT) ≥1.5 x ULN.

⁃ The use of full-dose oral or parenteral anticoagulants is permitted as long as the INR or APTT is within therapeutic limits (according to site medical standard). If the patient is on oral anticoagulants, dose has to be stable for at least two weeks at the time of randomization.

⁃ Urine dipstick for proteinuria \< 2+. If urine dipstick is ≥2+, 24-hour proteinuria must be \<1 g.

⁃ Normal blood pressure or adequately treated and controlled hypertension (systolic BP ≤ 140 mmHg and/or diastolic BP ≤ 90 mmHg).

⁃ Formalin fixed paraffin embedded (FFPE) tumor sample from the primary cancer must be available for local BRCA testing and if possible HRD testing (optional).

⁃ For countries where this will apply to: a subject will be eligible for randomization in this study only if either affiliated to, or a beneficiary of a social security category.

Locations
Other Locations
France
ICO Paul Papin
NOT_YET_RECRUITING
Angers
Sainte Catherine Institut du cancer Avignon-Provence
NOT_YET_RECRUITING
Avignon
CHRU Besançon - Hôpital Jean Minjoz
NOT_YET_RECRUITING
Besançon
Clinique Tivoli-Ducos
NOT_YET_RECRUITING
Bordeaux
Institut Bergonié
NOT_YET_RECRUITING
Bordeaux
Hôpital Morvan CHRU de Brest
NOT_YET_RECRUITING
Brest
HCL - Groupe Hospitalier Est
NOT_YET_RECRUITING
Bron
Centre François Baclesse
RECRUITING
Caen
Centre Hospitalier de Cholet
NOT_YET_RECRUITING
Cholet
Centre Jean Perrin
NOT_YET_RECRUITING
Clermont-ferrand
Centre Georges François Leclerc
NOT_YET_RECRUITING
Dijon
CHU de Dijon - Bourgogne
NOT_YET_RECRUITING
Dijon
Groupe Hospitalier Mutualiste de Grenoble - Institut Daniel Hollard
NOT_YET_RECRUITING
Grenoble
CHU Grenoble-Alpes - Site Nord (La Tronche)
NOT_YET_RECRUITING
La Tronche
Clinique Victor Hugo
NOT_YET_RECRUITING
Le Mans
Centre Oscar Lambret
NOT_YET_RECRUITING
Lille
CHU de Limoges - Hôpital Dupuytren
NOT_YET_RECRUITING
Limoges
Centre Léon Bérard
NOT_YET_RECRUITING
Lyon
HCL - Hôpital de la Croix Rousse
NOT_YET_RECRUITING
Lyon
Hôpital Privé Jean Mermoz
NOT_YET_RECRUITING
Lyon
Hôpital Nord Marseille
NOT_YET_RECRUITING
Marseille
Institut Paoli Calmettes
NOT_YET_RECRUITING
Marseille
CHU Montpellier - Hôpital Saint Eloi
NOT_YET_RECRUITING
Montpellier
Institut régional du cancer de Montpellier
NOT_YET_RECRUITING
Montpellier
Centre Azuréen de Cancérologie
NOT_YET_RECRUITING
Mougins
ORACLE - Centre d'Oncologie de Gentilly
NOT_YET_RECRUITING
Nancy
Hôpital Privé du Confluent
NOT_YET_RECRUITING
Nantes
Centre ONCOGARD - Institut de cancérologie du Gard
NOT_YET_RECRUITING
Nîmes
CHR Orléans
NOT_YET_RECRUITING
Orléans
Groupe Hospitalier Diaconesses - Croix Saint-Simon
NOT_YET_RECRUITING
Paris
Groupe Hospitalier Pitié Salpêtrière
NOT_YET_RECRUITING
Paris
Hôpital cochin
NOT_YET_RECRUITING
Paris
Hôpital Européen Georges Pompidou
NOT_YET_RECRUITING
Paris
Hôpital Saint-Joseph
NOT_YET_RECRUITING
Paris
Hôpital Tenon
NOT_YET_RECRUITING
Paris
Institut Mutualiste Montsouris
NOT_YET_RECRUITING
Paris
HCL - Centre Hospitalier Lyon Sud (Hospices Civils de Lyon)
RECRUITING
Pierre-bénite
Centre CARIO - HPCA
NOT_YET_RECRUITING
Plérin
CHU de Poitiers - Hôpital de la Milétrie
NOT_YET_RECRUITING
Poitiers
Institut Jean Godinot
NOT_YET_RECRUITING
Reims
Centre Eugène Marquis
NOT_YET_RECRUITING
Rennes
Centre Henri Becquerel
NOT_YET_RECRUITING
Rouen
ICO - Centre René Gauducheau
NOT_YET_RECRUITING
Saint-herblain
CHU de Saint-Etienne - Pôle de Cancérologie
NOT_YET_RECRUITING
Saint-priest-en-jarez
ICANS - Institut de cancérologie Strasbourg Europe
NOT_YET_RECRUITING
Strasbourg
Institut Claudius Regaud
RECRUITING
Toulouse
CHU Tours - Hôpital Bretonneau
NOT_YET_RECRUITING
Tours
CH Valence
NOT_YET_RECRUITING
Valence
Gustave Roussy
NOT_YET_RECRUITING
Villejuif
Italy
Firenze-Careggi
NOT_YET_RECRUITING
Florence
Fondazione IRCCS Istituto Nazionale dei Tumori
RECRUITING
Milan
Istituto Europeo di Oncologia (IEO)
RECRUITING
Milan
Ospedale San Gerardo Monza
RECRUITING
Monza
Presidio Ospedaliero di Sondrio
NOT_YET_RECRUITING
Sondrio
Japan
Ehime University Hospital
NOT_YET_RECRUITING
Ehime
National Cancer Center Hospital East
NOT_YET_RECRUITING
Kashiwanoha
Okayama University Hospital
NOT_YET_RECRUITING
Kita-ku
Kurume University Hospital Clinical Research Center
RECRUITING
Kurume
Niigata Cancer Center Hospital
RECRUITING
Niigata
Saitama Medical University International Medical Center
RECRUITING
Saitama
Jichi Medical UH
NOT_YET_RECRUITING
Shimotsuke
Cancer Institute Hospital Of JFCR
RECRUITING
Tokyo
University of Tsukuba Hospital
RECRUITING
Tsukuba
Yamagata University Hospital
NOT_YET_RECRUITING
Yamagata
Republic of Korea
Asan Medical Center
NOT_YET_RECRUITING
Seoul
National Cancer Center
RECRUITING
Seoul
National University Hospital
RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Severance Hospital
RECRUITING
Seoul
Singapore
National Cancer Centre Singapore
NOT_YET_RECRUITING
Singapore
National University Hospital (NUH)
NOT_YET_RECRUITING
Singapore
Spain
Coruña University Hospital (CHUAC)
RECRUITING
A Coruña
Hospital del Mar
RECRUITING
Barcelona
Hospital Universitari Dexeus
RECRUITING
Barcelona
Hospital San Pedro de Alcantara
RECRUITING
Cáceres
Hospital Clínico Universitario Virgen de la Arrixaca
RECRUITING
El Palmar, Murcia
Hospital Universitario de Jerez
NOT_YET_RECRUITING
Jerez De La Frontera
Clínica Universidad de Navarra
RECRUITING
Madrid
Hospital Universitario La Paz
NOT_YET_RECRUITING
Madrid
Hospital Universitario Puerta de Hierro
NOT_YET_RECRUITING
Madrid
Hospital Virgen de la Victoria
RECRUITING
Málaga
Hospital Universitario Central de Asturias
RECRUITING
Oviedo
Clinica Universidad de Navarra.
NOT_YET_RECRUITING
Pamplona
Complejo Hospitalario de Navarra
RECRUITING
Pamplona
CHU de Santiago de Compostela
RECRUITING
Santiago De Compostela
Hospital Universitari MutuaTerrassa
RECRUITING
Terrassa
Fundación Investigación Clínico de Valencia.
RECRUITING
Valencia
Contact Information
Primary
Sidonie Adam
sadam@arcagy.org
(0033) 1 84 85 20 18
Time Frame
Start Date: 2022-02-01
Estimated Completion Date: 2030-02
Participants
Target number of participants: 390
Treatments
Experimental: ARM A: carboplatin/paclitaxel + niraparib
carboplatin AUC 5-6 + paclitaxel 175 mg/m² q3w, 5 cycles, followed by niraparib 200\* or 300 mg/d for 2 years.
Experimental: ARM B: carboplatin/paclitaxel/bevaziumab + niraparib/bevacizumab
carboplatin AUC 5-6 + paclitaxel 175 mg/m² + bevacizumab 15 mg/kg q3w, 5 cycles, followed by bevacizumab 15 mg/kg q3w for 15 months + niraparib 200\*or 300 mg/d for 2 years.
Related Therapeutic Areas
Sponsors
Leads: ARCAGY/ GINECO GROUP

This content was sourced from clinicaltrials.gov

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