跳至主要内容
临床试验/NCT01810744
NCT01810744已完成不适用

Study of Microcirculatory Effects of Bevacizumab in Patients Treated for Metastatic Colon Cancer or Glioblastoma

Centre Georges Francois Leclerc2 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2013年5月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
47
试验地点
2
主要终点
change in the density of capillaries

研究概览

简要总结

The treatment of the most common cancers (colon, breast, lung, liver and kidney) has recently added a new therapeutic class known as the "anti-angiogenic". It was born from a better understanding of tumor growth requires the development of neo-vessels. These new vessels are of major importance for the viability of the tumor but also the birth of metastases. This neo-angiogenesis is complex and results from an imbalance between pro-angiogenic factors and anti-angiogenic factors. Growth factor VEGF and its receptors (VEGFR-1, VEGFR-2 and VEGFR-3) are a way of survival of endothelial cells required for tumor neoangiogenesis. The anti-angiogenic drugs currently available on the market are bevacizumab (Avastin ®), sunitinib (Sutent ®) and sorafenib (Nexavar ®). The mechanism of anti-angiogenic action of these three main drugs are pharmacological inhibition of the VEGF pathway.

These new anti-angiogenic therapies, however, have significant adverse effects are common and some other more serious but rare.

Hypertension is the most common side effect observed in patients treated with anti-VEGF. This is usually iatrogenic hypertension controlled by antihypertensive therapy and rarely compromises the pursuit of anti-angiogenic therapy. More rarely, it can have serious consequences malignant hypertension, severe hypertension refractory reversible posterior leukoencephalopathy associated with severe hypertension have also been reported.

The pathophysiology of hypertension may be due to the neutralization of major physiological effects of VEGF in endothelial cell and therefore the vascular wall.

The study of the microcirculation is not only useful in the diagnosis of microvascular but also macrovascular disease in the evaluation of chronic arterial and venous severe it determines the prognosis. In these indications, capillaroscopy remains the gold standard for all work pathophysiological because visualization of phenomena measured avoids artifacts and difficulties of interpretation. It then appealed to additional technology to directly measure the capillary pressure, capillary flow velocity, and indirectly assess capillary permeability and function of lymphatic canaliculi. The simplest of these technological inputs: video microscopy and digital image analysis, have also improved the practice of routine clinical capillaroscopy in its main field of application, evaluation of microangiopathy connective. The examination can be performed more quickly and easily archived and quantified.

Only two studies on 14 and 16 patients were able to see a decrease in capillary density correlated with the therapeutic activity of anti-angiogenic the tumor mass and metastasis.

Thus, we propose to quantify in a number of relatively large patient patients the decrease in capillary density as well as the relationship between the decrease in the number of capillaries and anti-tumor response.

The study will also aim to measure the prevalence of hypertension in patients treated with bevacizumab and to establish the link between these data and the modification of the capillary microcirculation.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years
  • signed informed Consent
  • Medical Examination
  • Patients with metastatic colorectal cancer
  • Patients with a glioblastoma
  • patient to receive treatment with bevacizumab not yet started
  • MRI for patients with glioblastoma or scanner TAP for patients carrying a metastatic colon cancer performed within 3 weeks before inclusion.

排除标准

  • Bevacizumab already initiated or history of antiangiogenic treatment
  • Inability legal (persons deprived of liberty or under guardianship)
  • Pregnant or lactating women
  • Can not sign consent or unable to undergo medical follow up for geographical, social or psychological reasons
  • Patients not covered by Medicare including CMU
  • Estimated life of over 3 months

研究组 & 干预措施

metastatic colorectal cancer

Other

Patients treated by bevacizumab will be follow up by capillaroscopy and blood pressure measurements.

干预措施: capillaroscopy (Other)

metastatic colorectal cancer

Other

Patients treated by bevacizumab will be follow up by capillaroscopy and blood pressure measurements.

干预措施: blood pressure measurement (Other)

glioblastoma

Other

Patients treated by bevacizumab will be follow up by capillaroscopy and blood pressure measurements.

干预措施: capillaroscopy (Other)

glioblastoma

Other

Patients treated by bevacizumab will be follow up by capillaroscopy and blood pressure measurements.

干预措施: blood pressure measurement (Other)

结局指标

主要结局

change in the density of capillaries

时间窗: baseline and after 15 days of bevacizumab treatment

The change in the density of capillaries visualized by periungual capillaroscopy will be quantify after 15 days of treatment with bevacizumab, in patients with metastatic colon cancer or a brain tumor.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

已完成
3 期
A Study of Bevacizumab (Avastin) in Combination With Chemotherapy in Participants With Metastatic Cancer of the Colon or Rectum.Colorectal Cancer
NCT01169558Hoffmann-La Roche168
已完成
1 期
Bevacizumab in Treating Patients With Advanced Solid TumorsUnspecified Adult Solid Tumor, Protocol Specific
NCT00416637Herbert Hurwitz, MD27
Unknown
2 期
Study of Bevacizumab Plus Chemotherapy in Patients With Metastatic Colorectal CancerColorectal Cancer
NCT01679327Chinese Academy of Medical Sciences100
已完成
1 期
Bevacizumab and BKM-120 in Patients With Metastatic Renal Cell CarcinomaRenal Cell Carcinoma
NCT01283048Toni Choueiri, MD32
已完成
1 期
Bevacizumab, Fluorouracil, and Hydroxyurea Plus Radiation Therapy in Treating Patients With Advanced Head and Neck CancerMetastatic Squamous Neck Cancer With Occult Primary Squamous Cell CarcinomaRecurrent Adenoid Cystic Carcinoma of the Oral CavityRecurrent Basal Cell Carcinoma of the LipRecurrent Esthesioneuroblastoma of the Paranasal Sinus and Nasal CavityRecurrent Inverted Papilloma of the Paranasal Sinus and Nasal CavityRecurrent Lymphoepithelioma of the NasopharynxRecurrent Lymphoepithelioma of the OropharynxRecurrent Metastatic Squamous Neck Cancer With Occult PrimaryRecurrent Midline Lethal Granuloma of the Paranasal Sinus and Nasal CavityRecurrent Mucoepidermoid Carcinoma of the Oral CavityRecurrent Salivary Gland CancerRecurrent Squamous Cell Carcinoma of the HypopharynxRecurrent Squamous Cell Carcinoma of the LarynxRecurrent Squamous Cell Carcinoma of the Lip and Oral CavityRecurrent Squamous Cell Carcinoma of the NasopharynxRecurrent Squamous Cell Carcinoma of the OropharynxRecurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal CavityRecurrent Verrucous Carcinoma of the LarynxRecurrent Verrucous Carcinoma of the Oral CavityStage III Adenoid Cystic Carcinoma of the Oral CavityStage III Basal Cell Carcinoma of the LipStage III Esthesioneuroblastoma of the Paranasal Sinus and Nasal CavityStage III Inverted Papilloma of the Paranasal Sinus and Nasal CavityStage III Lymphoepithelioma of the NasopharynxStage III Lymphoepithelioma of the OropharynxStage III Midline Lethal Granuloma of the Paranasal Sinus and Nasal CavityStage III Mucoepidermoid Carcinoma of the Oral CavityStage III Salivary Gland CancerStage III Squamous Cell Carcinoma of the HypopharynxStage III Squamous Cell Carcinoma of the LarynxStage III Squamous Cell Carcinoma of the Lip and Oral CavityStage III Squamous Cell Carcinoma of the NasopharynxStage III Squamous Cell Carcinoma of the OropharynxStage III Squamous Cell Carcinoma of the Paranasal Sinus and Nasal CavityStage III Verrucous Carcinoma of the LarynxStage III Verrucous Carcinoma of the Oral CavityStage IV Adenoid Cystic Carcinoma of the Oral CavityStage IV Basal Cell Carcinoma of the LipStage IV Esthesioneuroblastoma of the Paranasal Sinus and Nasal CavityStage IV Inverted Papilloma of the Paranasal Sinus and Nasal CavityStage IV Lymphoepithelioma of the NasopharynxStage IV Lymphoepithelioma of the OropharynxStage IV Midline Lethal Granuloma of the Paranasal Sinus and Nasal CavityStage IV Mucoepidermoid Carcinoma of the Oral CavityStage IV Salivary Gland CancerStage IV Squamous Cell Carcinoma of the HypopharynxStage IV Squamous Cell Carcinoma of the LarynxStage IV Squamous Cell Carcinoma of the Lip and Oral CavityStage IV Squamous Cell Carcinoma of the NasopharynxStage IV Squamous Cell Carcinoma of the OropharynxStage IV Squamous Cell Carcinoma of the Paranasal Sinus and Nasal CavityStage IV Verrucous Carcinoma of the LarynxStage IV Verrucous Carcinoma of the Oral CavityUntreated Metastatic Squamous Neck Cancer With Occult Primary
NCT00023959National Cancer Institute (NCI)39