Profile of Soluble and Cellular Biomarkers and of Functional Imaging During Antiangiogenic Therapies in Cancer Patients

This study is currently recruiting participants.
Verified January 2012 by Medical University Innsbruck
Sponsor:
Information provided by (Responsible Party):
Wolfgang Hilbe, Medical University Innsbruck
ClinicalTrials.gov Identifier:
NCT01507740
First received: September 18, 2009
Last updated: January 8, 2012
Last verified: January 2012

September 18, 2009
January 8, 2012
July 2009
December 2012   (final data collection date for primary outcome measure)
Progression free survival under antiangiogenic therapy [ Time Frame: progression of disease, up to 48 months ] [ Designated as safety issue: Yes ]
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
Same as current
Complete list of historical versions of study NCT01507740 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Profile of Soluble and Cellular Biomarkers and of Functional Imaging During Antiangiogenic Therapies in Cancer Patients
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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Consecutive serum and blood probes will be taken and will be examined and correlated with functional imaging and the clinical course. 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).

Non-Probability Sample
  • 10 NSCLC patients treated with bevacizumab monotherapy (maintenance therapy)
  • 10 RCC patients treated either with sorafenib or sunitinib monotherapy
  • 10 CRC patients treated with bevacizumab monotherapy
  • 10 HCC patients treated with sorafenib monotherapy
  • Hepatocellular Cancer
  • Non-small Cell Lung Cancer
  • Renal Cell Cancer
  • Colorectal Cancer
  • Drug: Avastin
    Dosage, duration, indications and contraindications of treatment rely on the sole responsibility of the treating physician and are not subject of the present study
  • Drug: Suntent
    Dosage, duration, indications and contraindications of treatment rely on the sole responsibility of the treating physician and are not subject of the present study
  • Drug: 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
  • 1
    Control group n=20
  • 2
    investigational group (cancer patients) n=40 patients treated with antiangiogenic agent
    Interventions:
    • Drug: Avastin
    • Drug: Suntent
    • Drug: Nexavar
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
November 2014
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age over 18 years
  • Patients with HCC, NSCLC, RCC or CRC treated with an approved antiangiogenic drug (bevacizumab, sorafenib, sunitinib)*
  • Patients with at least one measurable lesion. Lesions must be measurable by CT-scan or MRI (Magnetic resonance imaging) according to Response Evaluation Criteria in Solid Tumours (RECIST)

Exclusion Criteria:

  • Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. Both men and women enrolled in this trial must use adequate birth control measures during the course of the trial. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate.
  • Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
  • Known or suspected allergy to the investigational agent or any agent given in association with this trial -_> allergy
  • MRI contraindications: implants (pacemaker)
Both
18 Years and older
Yes
Contact: Andreas Pircher, Dr. 0043-512-504 ext 82430 andreas.pircher@i-med.ac.at
Austria
 
NCT01507740
Praemarker AAT 08
Yes
Wolfgang Hilbe, Medical University Innsbruck
Medical University Innsbruck
Not Provided
Principal Investigator: Wolfgang Hilbe, Prof Medical University Innsbruck
Medical University Innsbruck
January 2012

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