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

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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.


Condition Intervention
Hepatocellular Cancer
Non-small Cell Lung Cancer
Renal Cell Cancer
Colorectal Cancer
Drug: Avastin
Drug: Suntent
Drug: Nexavar

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by Medical University Innsbruck:

Primary Outcome Measures:
  • 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


Biospecimen Retention:   Samples With DNA

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).


Estimated Enrollment: 60
Study Start Date: July 2009
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Control group n=20
2
investigational group (cancer patients) n=40 patients treated with antiangiogenic agent
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
  • 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
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01507740

Contacts
Contact: Andreas Pircher, Dr. 0043-512-504 ext 82430 andreas.pircher@i-med.ac.at

Locations
Austria
University Hospital Innsbruck, Internal Medicine V, Hematology Oncology Recruiting
Innsbruck, Austria, A-6020
Contact: Andreas Pircher, Dr.    0043-512-504 ext 82430    andreas.pircher@i-med.ac.at   
Principal Investigator: Wolfgang Hilbe, Univ. Prof. Dr.         
Sponsors and Collaborators
Medical University Innsbruck
Investigators
Principal Investigator: Wolfgang Hilbe, Prof Medical University Innsbruck
  More Information

No publications provided

Responsible Party: Wolfgang Hilbe, Prof. Wolfgang Hilbe, Medical University Innsbruck
ClinicalTrials.gov Identifier: NCT01507740     History of Changes
Other Study ID Numbers: Praemarker AAT 08
Study First Received: September 18, 2009
Last Updated: January 8, 2012
Health Authority: Austria: Agency for Health and Food Safety

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Carcinoma, Renal Cell
Liver Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on October 19, 2014