Study of Clinical and Biological Prognostic Factors in Patients With Ovarian Cancer Receiving Carboplatin +Paclitaxel With Bevacizumab
MITO16/MANGO-2
A MULTICENTER STUDY IN PATIENTS WITH STAGE III-IV EPITHELIAL OVARIAN CANCER TREATED WITH CARBOPLATIN/PACLITAXEL WITH BEVACIZUMAB: CLINICAL AND BIOLOGICAL PROGNOSTIC FACTORS
2 other identifiers
interventional
400
1 country
47
Brief Summary
The addition of bevacizumab to first-line chemotherapy has been shown to improve progression free survival for patients with ovarian cancer. The purpose of this study is to explore the potential role of clinical and biologic factors in identifying those patients who benefit most from this combined therapy in terms of progression free and overall survival.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 ovarian-cancer
Started Oct 2012
Longer than P75 for phase_4 ovarian-cancer
47 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 10, 2012
CompletedFirst Posted
Study publicly available on registry
October 15, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedMarch 24, 2023
March 1, 2023
12.2 years
October 10, 2012
March 23, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
expression of soluble and tissutal biomarkers
measured at baseline, at completion of chemotherapy, at disease progression or bevacizumab completion up to 15 monthsfor each patient
Secondary Outcomes (5)
progression free survival
one year
overall survival
three years
worst grade toxicity per patient
evaluated every 3 weeks up to 15 month
number of patients taking oral antidiabetic therapy
at baseline
number of patients taking antithrombotic therapy
at baseline
Study Arms (1)
First-line chemotherapy with bevacizumab
OTHER* Bevacizumab 15 mg/kg i.v. on Day 1 every 3 weeks for up to 22 cycles * Paclitaxel 175 mg/m2 on Day 1 every 3 weeks for up to 6 cycles * Carboplatin (AUC 5) on Day 1 every 3 weeks for up to 6 cycles
Interventions
• Bevacizumab 15 mg/kg i.v. on Day 1 every 3 weeks up to 22 cycles
• Bevacizumab 15 mg/kg i.v. on Day 1 every 3 weeks up to 6 cycles
• Carboplatin (AUC 5) on Day 1 every 3 weeks for up to 6 cycles
Eligibility Criteria
You may qualify if:
- Female patients ≥18 years of age.
- Patients with histologically confirmed epithelial ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma, including mixed Mullerian Tumours Or Recurrent early stage epithelial ovarian or fallopian tube carcinoma treated with surgery alone.
- FIGO stage IIIB \& C or IV
- ECOG Performance Status of 0-2.
- Life expectancy of at least 12 weeks.
- Signed informed consent obtained prior to initiation of any study-specific procedures and treatment as confirmation of the patient's awareness and willingness to comply with the study requirements.
- Availability of tumour samples for molecular analyses
You may not qualify if:
- Cancer related
- Ovarian tumours with low malignant potential (i.e. borderline tumours)
- Previous systemic anti-cancer therapy for advanced ovarian cancer.
- History or evidence of brain metastases or spinal cord compression.
- History or evidence of synchronous primary endometrial carcinoma, unless all of the following criteria related to the endometrial carcinoma are met:
- stage ≤Ia
- no more than superficial myometrial invasion
- no lymphovascular invasion
- not poorly differentiated (grade 3 or papillary serous or clear cell carcinoma).
- Other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer.
- Other-treatment related
- Any prior radiotherapy to the pelvis or abdomen.
- Surgery (including open biopsy) within 4 weeks prior to the first bevacizumab dose or planned (In this case the patient can be enrolled but the administration of bevacizumab should be omitted at first cycle).
- Current or recent (within 10 days prior to the first study drug dose) use of full-dose oral or parenteral anticoagulant or thrombolytic agent for therapeutic purposes (except for central venous access patency, in which case international normalized ratio \[INR\] must be maintained below 1.5). Post operative prophylaxis with low molecular weight heparin sc is allowed.
- Current or recent (within 30 days of first study dosing) treatment with another investigational drug.
- +21 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (47)
A.S.O. SS Antonio e Biagio e Cesare Arrigo
Alessandria, Italy
Centro di Riferimento Oncologico
Aviano, Italy
Ospedale Fatebenefratelli
Benevento, Italy
Spedali Civili - Università di Brescia
Brescia, Italy
Ospedale Senatore Antonio Perrino
Brindisi, Italy
Fondazione del Piemonte per l'Oncologia
Candiolo, Italy
Ospedale Ramazzini di Carpi /Ospedale di Mirandola
Carpi, Italy
Azienda Ospedaliera Garibaldi Nesimadi Catania
Catania, Italy
Ospedale Cannizzaro
Catania, Italy
Ospedale Mater Domini
Catanzaro, Italy
Ospedale Civile di Faenza
Faenza, Italy
Ospedale Santa Croce
Fano, Italy
A.O.U. Arcispedale Sant'Anna di Ferrara
Ferrara, Italy
Ospedale Fabrizio Spaziani di Frosinone / Osp. SS Trinità di Sora
Frosinone, Italy
E.O. Ospedali Galliera
Genova, Italy
IRCCS San Martino IST
Genova, Italy
Ospedale di Guastalla
Guastalla, Italy
Ospedale A. Manzoni
Lecco, Italy
Ospedale Mater Salutis
Legnago, Italy
Presidio Ospedaliero Manerbio
Manerbio, Italy
A.O. C. Poma
Mantova, Italy
Istituto Romagnolo per lo Studio e la Cura dei Tumori
Meldola, Italy
Istituto Europeo di Oncologia
Milan, Italy
Istituto Nazionale Tumori
Milan, Italy
Ospedale San Raffaele
Milan, Italy
U.L.S.S. 13
Mirano, Italy
A.O.U. Policlinico Modena
Modena, Italy
Ospedale S. Gerardo
Monza, Italy
AOU Policlinico Federico II
Napoli, Italy
Istituto Nazionale dei Tumori
Napoli, Italy
Istituto Sacro Cuore Don Calabria
Negrar, Italy
Istituto Oncologico Veneto
Padua, Italy
Fondazione IRCCS S. Matteo
Pavia, Italy
Ospedale Silvestrini
Perugia, Italy
Ospedale Santa Chiara
Pisa, Italy
A.O. Santa Maria degli Angeli
Pordenone, Italy
Ospedale S. Maria delle Croci
Ravenna, Italy
Arcispedale S. Maria Nuova
Reggio Emilia, Italy
Ospedale degli Infermi / Ospedale Civile
Rimini, Italy
Istituto Regina Elena
Roma, Italy
Ospedale S. Giovanni Calibita Fatebenefratelli
Roma, Italy
Policlinico Universitario Gemelli Università Cattolica del Sacro Cuore
Roma, Italy
A.O. Ordine Mauriziano
Torino, Italy
A.O.U. OIRM-S. Anna
Torino, Italy
ASS N 1 Triestina
Trieste, Italy
A.O. di Udine S. Maria delle Misericordia
Udine, Italy
Ospedale del Ponte
Varese, Italy
Related Publications (2)
Di Liello R, Arenare L, Raspagliesi F, Scambia G, Pisano C, Colombo N, Frezzini S, Tognon G, Artioli G, Gadducci A, Lauria R, Ferrero A, Cinieri S, De Censi A, Breda E, Scollo P, De Giorgi U, Lissoni AA, Katsaros D, Lorusso D, Salutari V, Cecere SC, Lapresa M, Nardin M, Bogani G, Distefano M, Greggi S, Gargiulo P, Schettino C, Gallo C, Daniele G, Califano D, Perrone F, Pignata S, Piccirillo MC. Thromboembolic events and antithrombotic prophylaxis in advanced ovarian cancer patients treated with bevacizumab: secondary analysis of the phase IV MITO-16A/MaNGO-OV2A trial. Int J Gynecol Cancer. 2021 Oct;31(10):1348-1355. doi: 10.1136/ijgc-2021-002786. Epub 2021 Aug 30.
PMID: 34462317DERIVEDDaniele G, Raspagliesi F, Scambia G, Pisano C, Colombo N, Frezzini S, Tognon G, Artioli G, Gadducci A, Lauria R, Ferrero A, Cinieri S, De Censi A, Breda E, Scollo P, De Giorgi U, Lissoni AA, Katsaros D, Lorusso D, Salutari V, Cecere SC, Zaccarelli E, Nardin M, Bogani G, Distefano M, Greggi S, Piccirillo MC, Fossati R, Giannone G, Arenare L, Gallo C, Perrone F, Pignata S. Bevacizumab, carboplatin, and paclitaxel in the first line treatment of advanced ovarian cancer patients: the phase IV MITO-16A/MaNGO-OV2A study. Int J Gynecol Cancer. 2021 Jun;31(6):875-882. doi: 10.1136/ijgc-2021-002434. Epub 2021 Apr 30.
PMID: 33931498DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sandro Pignata, M.D., Ph.D.
National Cancer Institute, Naples
- PRINCIPAL INVESTIGATOR
Nicoletta Colombo, M.D.
European Institute of Oncology
- PRINCIPAL INVESTIGATOR
Francesco Perrone, M.D., Ph.D.
National Cancer Institute, Naples
- PRINCIPAL INVESTIGATOR
Gennaro Daniele, M.D., Ph.D.
National Cancer Institute, Naples
- PRINCIPAL INVESTIGATOR
Roldano Fossati, M.D.
Mario Negri Institute
- PRINCIPAL INVESTIGATOR
Ciro Gallo, M.D.
University of Campania Luigi Vanvitelli
- PRINCIPAL INVESTIGATOR
Irene Floriani, Ph.D.
Mario Negri Institute
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 10, 2012
First Posted
October 15, 2012
Study Start
October 1, 2012
Primary Completion
December 1, 2024
Study Completion
December 1, 2024
Last Updated
March 24, 2023
Record last verified: 2023-03