Ovarian Cancer
Conditions
Keywords
ovarian cancer, angiopoietin 1, tunica interna endothelial cell kinase 2, VEGF, bevacizumab
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.
Interventions
OTHERObservational study. Blood samples will be collected at scheduled blood draws performed as per clinical practice before each cycle of chemotherapy.
Collection of blood samples during blood draws performed before each cycle of chemotherapy as per clinical practice.
Sponsors
Ospedale SS Giovanni e Paolo, Venezia
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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 ).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
Countries
Italy
Contacts
Primary ContactClaudio Zamagni, MD
Outcome results
None listed