Evaluation of the Predictive Value of Blood Levels of Angiopoietin 1 and Endothelial Internal Tunica Cell Kinase 2 in Patients With Ovarian Cancer Treated With Chemotherapy Associated to Bevacizumab

IRCCS Azienda Ospedaliero-Universitaria di Bologna150 enrolled

Overview

This is a monocentric prospective observational pilot study of translational research in women with advanced ovarian epithelial cancer. The main purpose of this study is to evaluate the predictive value of response to treatment with bevacizumab of the circulating levels of Ang1, Tie2 and VEGF before start of therapy. Secondary aims of the study are to explore the predictive value of response / resistance to bevacizumab of changes in circulating levels of Ang1 and Tie2 during treatment and at progression of disease, and to explore the possible role of circulating VEGF in the modulation of bioavailability of bevacizumab.

Study Type

OBSERVATIONAL

Enrollment

150

Conditions

Ovarian Cancer

Interventions

Observational study. Blood samples will be collected at scheduled blood draws performed as per clinical practice before each cycle of chemotherapy.OTHER

Collection of blood samples during blood draws performed before each cycle of chemotherapy as per clinical practice.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients ≥ 18 years old * Diagnosis of histologically confirmed advanced epithelial ovarian carcinoma * Women eligible for treatment with a chemotherapy regimen in combination to bevacizumab (Cohort A) * Women eligible for treatment with a chemotherapy regimen not associated to antiangiogenic drugs (Cohort B) * Evaluable disease according to RECIST 1.1 criteria * Patient informed consent signature prior to any study-specific procedure Exclusion Criteria: * History of other malignancy within 5 years prior to study entry (except for cutaneous basal cell carcinoma or adequately treated carcinoma in situ of the cervix ).

Outcomes

Primary Outcomes

relationship between Ang1 and Tie2 values and response to treatment with bevacizumab

Relationship between baseline values of Ang1 and Tie2 (considered individually or combined with each other) and response to treatment with bevacizumab (according to RECIST 1.1 criteria).

Time frame: Before start of chemotherapy

relationship between VEGF values and response to treatment with bevacizumab

Relationship between baseline values of endogenous VEGF (plasma CTAD levels) and released by platelets during the clot phase (serum levels) and response to treatment with bevacizumab.

Time frame: Before start of chemotherapy

Secondary Outcomes

relationship between Ang1 and Tie2 levels

relationship between Ang1 and Tie2 levels at baseline, during chemotherapy administration and at progression of disease.

Time frame: from baseline (before start of chemotherapy) to 52 weeks from start of chemotherapy or progression of disease

anticipation of diagnosis of progression of disease

possible anticipation of diagnosis of progression of disease through evaluation of Ang1 and Tie2

Time frame: from baseline (before start of chemotherapy) to 52 weeks from start of chemotherapy or progression of disease

VEGF evaluation

Evaluation of free VEGF, bevacizumab-bound VEGF and available bevacizumab in relation to clinical response

Time frame: from baseline (before start of chemotherapy) to 52 weeks from start of chemotherapy or progression of disease

Evaluation of the Predictive Value of Blood Levels of Angiopoietin 1 and Endothelial Internal Tunica Cell Kinase 2 in Patients With Ovarian Cancer Treated With Chemotherapy Associated to Bevacizumab

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts