Prospective Pilot Study for the Evaluation of the Predictive Value of Blood Levels of Angiopoietin 1 (ANG1) and Endothelial Internal Tunica Cell Kinase 2 (TiE2) in Patients With Ovarian Cancer Treated With Chemotherapy Associated to bevAcizumab
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- relationship between VEGF values and response to treatment with bevacizumab
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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 ).
结局指标
主要结局
relationship between VEGF values and response to treatment with bevacizumab
时间窗: 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
时间窗: 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).
次要结局
- anticipation of diagnosis of progression of disease(from baseline (before start of chemotherapy) to 52 weeks from start of chemotherapy or progression of disease)
- VEGF evaluation(from baseline (before start of chemotherapy) to 52 weeks from start of chemotherapy or progression of disease)
- relationship between Ang1 and Tie2 levels(from baseline (before start of chemotherapy) to 52 weeks from start of chemotherapy or progression of disease)
研究者
Claudio Zamagni MD
MD Medical Oncologist
IRCCS Azienda Ospedaliero-Universitaria di Bologna