The effect of bevacizumab on taxanes-mediated release of growth factors and bone marrow derived endothelial progenitor cells.

The effect of bevacizumab on taxanes-mediated release of growth factors and bone marrow derived endothelial progenitor cells. - endothelial cell-platelet study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON31128

Enrollment

Registered

2007-09-03

Start date

2007-09-01

Completion date

Unknown

Last updated

2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cancer malignancy

Interventions

Patients will be randomly assigned to cohorts, with or without a predose consisting of bevacizumab. Other interventions include venapunctures for bloodsampling.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: The patient will have a previous diagnosis of histologically or cytologically documented solid tumor. The patient will start a taxane containing regimen as first or second line chemotherapy according to standard treatment guidelines for the underlying disease. Patients with metastatic or locally advanced breast cancer will be eligible. The patient has given written informed consent. The patient is willing and able to comply with protocol procedures. The patient must be *18 years of age. The patient will have not received any chemotherapy or biological therapy within the last 28 days and has recovered from any acute effects. Performance status WHO 0-2

Exclusion criteria

Exclusion criteria: Surgery

Design outcomes

Primary

Measure	Time frame
To clarify the mechanism of the occurrence of the endothelial progenitor cell burst that occurs after chemotherapy by : Determining the effect of taxane therapy on the release of bone marrow derived progenitor endothelial cells. Studying the effect of bevacizumab on taxane induced release of bone marrow derived progenitor endothelial cells	—

Secondary

Measure	Time frame
To explore whether there is a difference in progenitor cell dynamics between paclitaxel and docetaxel and a weekly or threeweekly regimen. To determine whether anti-angiogenic treatment affect platelet biology by testing: 1) Whether anti-angiogenic treatment impairs the angiogenic activity of isolated platelets from patients receiving bevacizumab treatment by using an endothelial cell proliferation assay as a potential biomarker for bevacizumab activity. 2) Whether platelets markers of activation can be detected in platelet samples or plasma from patients receiving bevacizumab treatment. 3) Whether platelet function is changed in aggregation and activation studies in vitro of isolated platelets from patients receiving bevacizumab treatment.	—

Measure

Time frame

To explore whether there is a difference in progenitor cell dynamics between paclitaxel and docetaxel and a weekly or threeweekly regimen. To determine whether anti-angiogenic treatment affect platelet biology by testing: 1) Whether anti-angiogenic treatment impairs the angiogenic activity of isolated platelets from patients receiving bevacizumab treatment by using an endothelial cell proliferation assay as a potential biomarker for bevacizumab activity. 2) Whether platelets markers of activation can be detected in platelet samples or plasma from patients receiving bevacizumab treatment. 3) Whether platelet function is changed in aggregation and activation studies in vitro of isolated platelets from patients receiving bevacizumab treatment.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)