Profile of soluble and cellular biomarkers and of functional imaging during antiangiogenic therapies in cancer patients - PRAEMARKERAAT08

Conditions: The present project is an academic clinical trial in which patient suffering from hepatocellular carcinoma, non-small cell lung cancer, renal cell cancer and colorectal cancer treated routinely with antiangiogenic agents. The study protocol intends to include ten patients per tumour entitity (n=40), treated either with Sorafenib (Nexavar), Bevacizumab (Avastin) or Sunitinib (Sutent), which are all approved antiangiogenic drugs in Austria in one of the cancer types defined above.

Registration Number: EUCTR2008-008852-18-AT

Lead Sponsor: Medizinische Universität Innsbruck Innere Medizin V

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Histological confirmed Tumor specimen RCC, HCC, CRC or NSCLC
Measurable disease according to RECIST criteria
Age: 18-80 years
Antiangiogenic Monotherapy (Avastin, Nexavar or Sutent)
WHO 0-2
Life expectancy of more than 3 months

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Prior or concurrent antitumor therapy (<3 weeks)
Pregnant or lactating patients
Preconditions in which MRI is contraindicated (claustrophopia, certain metal implants, others)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Biomarker evaluation under antiannagiogenic therapy with Nexavar, Sutent and Avastin. Eligible patients are suffering from hepatocellular carcinoma, non small cell lung cancer, renal cell cancer and colorectal cancer routinely treated with the abov mentioned antiangiogenic agents.;Secondary Objective: ;Primary end point(s): Evaluation of biomarker analyses

Secondary Outcome Measures