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

Recruiting

• Conditions: Ovarian Cancer
• Interventions: Other: Observational study. Blood samples will be collected at scheduled blood draws performed as per clinical practice before each cycle of chemotherapy.

• Registration Number: NCT04770376
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-12
• Study First Submitted: 2021-02-22
• Study First Submitted QC: 2021-02-22
• Study First Posted: 2021-02-25
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-28
• Last Update Posted: 2022-12-29
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 150

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 ).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort A: patients treated with chemotherapy (I-II line) associated to bevacizumab	Observational study. Blood samples will be collected at scheduled blood draws performed as per clinical practice before each cycle of chemotherapy.	Quantification of biomarkers will be performed on 100 patients treated with bevacizumab through the collection of the following samples at different timepoints: 1 serum sample; 2 CTAD plasma samples; 2 K2EDTA plasma samples. The samples will be collected as follows: before the start of chemotherapy; 3 weeks after start of chemotherapy, before start of treatment with bevacizumab; 9 weeks after start of chemotherapy; 15 weeks after start of chemotherapy; 52 weeks after start of chemotherapy; at progression of disease.
Cohort B: patients treated with chemotherapy (I-II line, not associated to antiangiogenic drugs)	Observational study. Blood samples will be collected at scheduled blood draws performed as per clinical practice before each cycle of chemotherapy.	Quantification of biomarkers will be performed on 50 patients treated with chemotherapy through the collection of the following samples at different timepoints: 1 serum sample; 2 CTAD plasma samples; 2 K2EDTA plasma samples. The samples will be collected as follows: before the start of chemotherapy; 3 weeks after start of chemotherapy, before start of treatment with bevacizumab; 9 weeks after start of chemotherapy; 15 weeks after start of chemotherapy; 52 weeks after start of chemotherapy; at progression of disease.

Primary Outcome Measures

Name	Time	Method
relationship between VEGF values and response to treatment with bevacizumab	Before start of chemotherapy	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.
relationship between Ang1 and Tie2 values and response to treatment with bevacizumab	Before start of chemotherapy	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).

Secondary Outcome Measures

Name	Time	Method
anticipation of diagnosis of progression of disease	from baseline (before start of chemotherapy) to 52 weeks from start of chemotherapy or progression of disease	possible anticipation of diagnosis of progression of disease through evaluation of Ang1 and Tie2
VEGF evaluation	from baseline (before start of chemotherapy) to 52 weeks from start of chemotherapy or progression of disease	Evaluation of free VEGF, bevacizumab-bound VEGF and available bevacizumab in relation to clinical response
relationship between Ang1 and Tie2 levels	from baseline (before start of chemotherapy) to 52 weeks from start of chemotherapy or progression of disease	relationship between Ang1 and Tie2 levels at baseline, during chemotherapy administration and at progression of disease.

Trial Locations

Locations (1)

Azienda Ospedaliero-Universitaria di Bologna, Policlinico S. Orsola-Malpighi, SSD Oncologia Medica Addarii; 🇮🇹 Bologna, Italy