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

NCT01507740 | Terminated DMC

• 1 other identifier: Praemarker AAT 08
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatocellular Cancer; Non-small Cell Lung Cancer; Renal Cell Cancer; Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Progression free survival under antiangiogenic therapy

  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

  progression of disease, up to 48 months

Study Arms (2)

1

Control group n=20

2

investigational group (cancer patients) n=40 patients treated with antiangiogenic agent

Drug: Avastin; Drug: Suntent; Drug: Nexavar

Interventions

Avastin DRUG

Dosage, duration, indications and contraindications of treatment rely on the sole responsibility of the treating physician and are not subject of the present study

2

Suntent DRUG

Dosage, duration, indications and contraindications of treatment rely on the sole responsibility of the treating physician and are not subject of the present study

2

Nexavar DRUG

Dosage, duration, indications and contraindications of treatment rely on the sole responsibility of the treating physician and are not subject of the present study

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Medical University Innsbruck: lead

Study Sites (1)

University Hospital Innsbruck, Internal Medicine V, Hematology Oncology

Innsbruck, A-6020, Austria

Location

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).

MeSH Terms

Conditions

Liver Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Colorectal Neoplasms

Interventions

Bevacizumab; Sorafenib

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Wolfgang Hilbe, Prof

  Medical University Innsbruck

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Wolfgang Hilbe

Study Record Dates

• First Submitted: September 18, 2009
• First Posted: January 11, 2012
• Study Start: July 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: October 1, 2014
• Last Updated: April 29, 2015

Record last verified: 2015-04

Locations

AU (1)