NCT01706120

Study of Clinical and Biological Prognostic Factors in Patients With Ovarian Cancer Receiving Carboplatin +Paclitaxel With Bevacizumab

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: National Cancer Institute, Naples · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	Bevacizumab	• Bevacizumab 15 mg/kg i.v. on Day 1 every 3 weeks up to 22 cycles
DRUG	Paclitaxel	• Bevacizumab 15 mg/kg i.v. on Day 1 every 3 weeks up to 6 cycles
DRUG	Carboplatin	• Carboplatin (AUC 5) on Day 1 every 3 weeks for up to 6 cycles

Timeline

• Start date: 2012-10-01
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2012-10-15
• Last updated: 2023-03-24

Locations

47 sites across 1 country: Italy