Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Ospedale SS Giovanni e Paolo, Venezia | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A: patients treated with chemotherapy (I-II line) associated to bevacizumab | 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) | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | Before start of chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| relationship between Ang1 and Tie2 levels | relationship between Ang1 and Tie2 levels at baseline, during chemotherapy administration and at progression of disease. | from baseline (before start of chemotherapy) to 52 weeks from start of chemotherapy or progression of disease |
| anticipation of diagnosis of progression of disease |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
A sample size of 100 patients with advanced epithelial ovarian carcer is expected to be enrolled in Cohort A (I-II line of chemotherapy associated to bevacizumab) and 50 patients with advanced epithelial ovarian carcer is expected to be enrolled in Cohort B (I-II line of chemotherapy, not associated to antiangiogenic drugs)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Claudio Zamagni, MD | Contact | 051 2144548 | + 39 | zamagniclaudio.sper@aosp.bo.it |
| Name | Affiliation | Role |
|---|---|---|
| Claudio Zamagni, MD | Policlinico S.Orsola-Malpighi, SSD Oncologia Medica Addarii | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliero-Universitaria di Bologna, Policlinico S. Orsola-Malpighi, SSD Oncologia Medica Addarii | Recruiting | Bologna | 40138 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26126494 | Background | Gadducci A, Lanfredini N, Sergiampietri C. Antiangiogenic agents in gynecological cancer: State of art and perspectives of clinical research. Crit Rev Oncol Hematol. 2015 Oct;96(1):113-28. doi: 10.1016/j.critrevonc.2015.05.009. Epub 2015 Jun 16. | |
| 25225422 | Background | Oliver KE, McGuire WP. Ovarian cancer and antiangiogenic therapy: caveat emptor. J Clin Oncol. 2014 Oct 20;32(30):3353-6. doi: 10.1200/JCO.2014.57.4574. Epub 2014 Sep 15. No abstract available. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
serum and plasma samples
possible anticipation of diagnosis of progression of disease through evaluation of Ang1 and Tie2 |
| 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 | from baseline (before start of chemotherapy) to 52 weeks from start of chemotherapy or progression of disease |
| 24947924 | Background | Backen A, Renehan AG, Clamp AR, Berzuini C, Zhou C, Oza A, Bannoo S, Scherer SJ, Banks RE, Dive C, Jayson GC. The combination of circulating Ang1 and Tie2 levels predicts progression-free survival advantage in bevacizumab-treated patients with ovarian cancer. Clin Cancer Res. 2014 Sep 1;20(17):4549-4558. doi: 10.1158/1078-0432.CCR-13-3248. Epub 2014 Jun 19. |
| 27351218 | Background | Zhou C, Clamp A, Backen A, Berzuini C, Renehan A, Banks RE, Kaplan R, Scherer SJ, Kristensen GB, Pujade-Lauraine E, Dive C, Jayson GC. Systematic analysis of circulating soluble angiogenesis-associated proteins in ICON7 identifies Tie2 as a biomarker of vascular progression on bevacizumab. Br J Cancer. 2016 Jul 12;115(2):228-35. doi: 10.1038/bjc.2016.194. Epub 2016 Jun 28. |
| 30405103 | Background | Jayson GC, Zhou C, Backen A, Horsley L, Marti-Marti K, Shaw D, Mescallado N, Clamp A, Saunders MP, Valle JW, Mullamitha S, Braun M, Hasan J, McEntee D, Simpson K, Little RA, Watson Y, Cheung S, Roberts C, Ashcroft L, Manoharan P, Scherer SJ, Del Puerto O, Jackson A, O'Connor JPB, Parker GJM, Dive C. Plasma Tie2 is a tumor vascular response biomarker for VEGF inhibitors in metastatic colorectal cancer. Nat Commun. 2018 Nov 7;9(1):4672. doi: 10.1038/s41467-018-07174-1. |
| 25691775 | Background | Ciccolini J, Serdjebi C, Barbolosi D, Lacarelle B, Barlesi F. Ang1 and Tie2 are predictive biomarkers for bevacizumab-letter. Clin Cancer Res. 2015 Feb 15;21(4):934. doi: 10.1158/1078-0432.CCR-14-2832. No abstract available. |
| 17470880 | Background | Loupakis F, Falcone A, Masi G, Fioravanti A, Kerbel RS, Del Tacca M, Bocci G. Vascular endothelial growth factor levels in immunodepleted plasma of cancer patients as a possible pharmacodynamic marker for bevacizumab activity. J Clin Oncol. 2007 May 1;25(13):1816-8. doi: 10.1200/JCO.2006.10.3051. No abstract available. |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
Not provided
Not provided