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.
MITO-16 - MANGO-OV2 is a single-arm, open-label, non-comparative, multicenter, phase IV study. Patients will receive a combination of bevacizumab, paclitaxel and carboplatin as first line treatment (in-label dose and scheduling). This is an exploratory study attempting to identify potential prognostic clinical factors(such as hypertension) and prognostic biologic factors. Overall, 2 types of biomarkers are considered. Dynamic biomarkers are those expressing the changing nature of the disease in relation to the treatment or simply the tumour progression, these are typically not inherited. Genetic biomarkers are typically inherited and are expression of some characteristics potentially able to interfere with the treatment effect (i.e. Pharmacogenomics). The safety of this regimen in routine clinical practice will also be described.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
400
• 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
expression of soluble and tissutal biomarkers
Time frame: measured at baseline, at completion of chemotherapy, at disease progression or bevacizumab completion up to 15 monthsfor each patient
progression free survival
Time frame: one year
overall survival
Time frame: three years
worst grade toxicity per patient
according to Common Toxicity Criteria for Adverse Events v. 4.03
Time frame: evaluated every 3 weeks up to 15 month
number of patients taking oral antidiabetic therapy
Time frame: at baseline
number of patients taking antithrombotic therapy
Time frame: at baseline
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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
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