Profile of Soluble and Cellular Biomarkers and of Functional Imaging During Antiangiogenic Therapies in Cancer Patients
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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 |
- 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
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| Contact: Andreas Pircher, Dr. | 0043-512-504 ext 82430 | andreas.pircher@i-med.ac.at |
| 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. | |
| 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 Carcinoma, Renal Cell Colorectal Neoplasms Liver Neoplasms Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Adenocarcinoma Carcinoma |
Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Kidney Neoplasms Urologic Neoplasms Urogenital Neoplasms Kidney Diseases Urologic Diseases Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |
ClinicalTrials.gov processed this record on June 17, 2013