Profile of Soluble and Cellular Biomarkers and of Functional Imaging During Antiangiogenic Therapies in Cancer Patients
Tumour angiogenesis has been identified to play a critical role in tumour growth and this knowledge has led to the identification of new targets for cancer therapy. Multiple angiogenic factors are involved in the regulation of angiogenesis, among them VEGF (vascular endothelial growth factor) and its receptor are of crucial relevance. The inhibition of VEGF signaling by monoclonal antibodies or small molecules (kinase inhibitors) has already been successfully established for the treatment of different cancer entities and multiple new drugs are being tested in clinical trials. The ever-expanding list of antiangiogenic agents being available in the near future will raise the questions when to use which agent and in which sequence. As a consequence biomarkers are going to be indispensible tools for choosing the most effective drugs and to predict dosing and resistance.
The present project is based on an academic clinical trial in which patients suffering from different cancer types (colorectal cancer, non-small cell lung cancer, renal cell cancer and hepatocellular cancer) treated routinely with antiangiogenic agents will be included. Consecutive serum and blood probes will be taken and will be examined and correlated with functional imaging and the clinical course. The following parameters have been selected: soluble markers in the plasma (VEGF, bFGF, ICAM, sVGFR-2 IL-8, SDF1 and Dickkopf 3) and cellular parameters like circulating endothelial cells (CEC) and circulating endothelial progenitor cells (CEPs).
In conclusion, the present project is screening for potential biomarkers and biomarker combinations relevant for antiangiogenic drugs in different tumour types. The predictive value of such profiles should then be evaluated in larger cohorts. In the future such profiles could possibly help clinicians to use these agents more effectively and therefore also more economically.
|Hepatocellular Cancer Non-small Cell Lung Cancer Renal Cell Cancer Colorectal Cancer||Drug: Avastin Drug: Suntent Drug: Nexavar|
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Profile of Soluble and Cellular Biomarkers and of Functional Imaging During Antiangiogenic Therapies in Cancer Patients|
- Progression free survival under antiangiogenic therapy [ Time Frame: progression of disease, up to 48 months ]From date of study inclusion until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months
Biospecimen Retention: Samples With DNA
|Study Start Date:||July 2009|
|Study Completion Date:||October 2014|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Control group n=20
investigational group (cancer patients) n=40 patients treated with antiangiogenic agent
Dosage, duration, indications and contraindications of treatment rely on the sole responsibility of the treating physician and are not subject of the present studyDrug: Suntent
Dosage, duration, indications and contraindications of treatment rely on the sole responsibility of the treating physician and are not subject of the present studyDrug: Nexavar
Dosage, duration, indications and contraindications of treatment rely on the sole responsibility of the treating physician and are not subject of the present study
Please refer to this study by its ClinicalTrials.gov identifier: NCT01507740
|University Hospital Innsbruck, Internal Medicine V, Hematology Oncology|
|Innsbruck, Austria, A-6020|
|Principal Investigator:||Wolfgang Hilbe, Prof||Medical University Innsbruck|