Suspended

MITO16/MANGO-2A MULTICENTER STUDY IN PATIENTS WITH STAGE III-IV EPITHELIAL OVARIAN CANCER TREATED WITH CARBOPLATIN/PACLITAXEL WITH BEVACIZUMAB: CLINICAL AND BIOLOGICAL PROGNOSTIC FACTORS

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Bevacizumab

+ Paclitaxel

+ Carboplatin

Drug
Who is being recruted

Urogenital Diseases+12

+ Genital Diseases

+ Adnexal Diseases

Over 18 Years
+27 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: October 2012
See protocol details

Summary

Principal SponsorNational Cancer Institute, Naples
Last updated: March 24, 2023
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01706120
Principal SponsorNational Cancer Institute, Naples
Last updated: March 24, 2023
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

400 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesAdnexal DiseasesEndocrine System DiseasesEndocrine Gland NeoplasmsFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleGenital Neoplasms, FemaleGonadal DisordersNeoplasmsNeoplasms by SiteOvarian DiseasesUrogenital NeoplasmsFemale Urogenital DiseasesOvarian Neoplasms

Criteria

7 inclusion criteria required to participate
Availability of tumour samples for molecular analyses
ECOG Performance Status of 0-2
FIGO stage IIIB & C or IV
Female patients >= 18 years of age
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20 exclusion criteria prevent from participating
Any prior radiotherapy to the pelvis or abdomen
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
Evidence of any other medical conditions (such as psychiatric illness, peptic ulcer, etc.), physical examination or laboratory findings that may interfere with the planned treatment, affect patient compliance or place the patient at high risk from treatment-related complications
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 47 locations

A.S.O. SS Antonio e Biagio e Cesare Arrigo

Alessandria, ItalyOpen A.S.O. SS Antonio e Biagio e Cesare Arrigo in Google Maps

Centro di Riferimento Oncologico

Aviano, Italy

Ospedale Fatebenefratelli

Benevento, Italy

Spedali Civili - Università di Brescia

Brescia, Italy
Suspended47 Study Centers