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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Centre Georges Francois Leclerc
Sponsor:
Information provided by (Responsible Party):
Centre Georges Francois Leclerc
ClinicalTrials.gov Identifier:
NCT01810744
First received: March 12, 2013
Last updated: September 25, 2013
Last verified: September 2013

March 12, 2013
September 25, 2013
May 2013
January 2016   (final data collection date for primary outcome measure)
change in the density of capillaries [ Time Frame: baseline and after 15 days of bevacizumab treatment ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01810744 on ClinicalTrials.gov Archive Site
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Study of Microcirculatory Effects of Bevacizumab in Patients Treated for Metastatic Colon Cancer or Glioblastoma
Study of Microcirculatory Effects of Bevacizumab in Patients Treated for Metastatic Colon Cancer or Glioblastoma

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.

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Interventional
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Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Metastatic Colorectal Cancer
  • Glioblastoma
  • Bevacizumab
  • Capillaroscopy
  • Other: capillaroscopy
  • Other: blood pressure measurement
  • metastatic colorectal cancer
    Patients treated by bevacizumab will be follow up by capillaroscopy and blood pressure measurements.
    Interventions:
    • Other: capillaroscopy
    • Other: blood pressure measurement
  • glioblastoma
    Patients treated by bevacizumab will be follow up by capillaroscopy and blood pressure measurements.
    Interventions:
    • Other: capillaroscopy
    • Other: blood pressure measurement
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
98
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January 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
Both
18 Years and older
No
Contact: Jérémy SKRZYPSKI, PHD 3 80 73 75 00 (3461) ext +33 jskrzypski@cgfl.fr
Contact: Sandrine TIAGO 3 45 34 80 51 ext +33 stiago@cgfl.fr
France
 
NCT01810744
001-FANI-2012
No
Centre Georges Francois Leclerc
Centre Georges Francois Leclerc
Not Provided
Principal Investigator: François Ghiringhelli, Professor Centre Georges Francois Leclerc
Centre Georges Francois Leclerc
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP