Hepatocellular CancerNCT01507740
Profile of Soluble and Cellular Biomarkers and of Functional Imaging During Antiangiogenic Therapies in Cancer Patients
An observational study of Hepatocellular Cancer and Non-small Cell Lung Cancer, run by Medical University Innsbruck at 1 site in Austria.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatocellular Cancer, Non-small Cell Lung Cancer, Renal Cell Cancer
- What is being tested?
- Avastin, Suntent and Nexavar
- How many people
- 60 participants
- Where
- 1 siteAustria
- Study dates
- Jul 2009to Oct 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Austria1 site
University Hospital Innsbruck, Internal Medicine V, Hematology Oncology
Innsbruck, A-6020
About this study
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.
- Being tested
- Avastin, Suntent, Nexavar
- Medical subject headings
- Liver Neoplasms, Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AvastinDrug
Dosage, duration, indications and contraindications of treatment rely on the sole responsibility of the treating physician and are not subject of the present study
SuntentDrug
Dosage, duration, indications and contraindications of treatment rely on the sole responsibility of the treating physician and are not subject of the present study
NexavarDrug
Dosage, duration, indications and contraindications of treatment rely on the sole responsibility of the treating physician and are not subject of the present study
| Study group | Role | What they receive |
|---|---|---|
| 1 | Control group n=20 | |
| 2 | investigational group (cancer patients) n=40 patients treated with antiangiogenic agent Receives: Drug: Avastin; Drug: Suntent; Drug: Nexavar |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: progression of disease, up to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2012 (estimated)
- Study startJul 2009
- Primary completionDec 2012
- Study completionOct 2014
Why it stopped: Study was stopped 04.10.2014 prematurly after recruitment of HCC and RCC patients. NSCLC (2 of 10 patients planned) and CRC patients recruitment was stopped
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CancerStudies of the same condition, open and under way.
- More trials run by Medical University InnsbruckThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wolfgang Hilbe, Medical University Innsbruck
- Investigators
- Wolfgang Hilbe, Prof, Principal investigator, Medical University Innsbruck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01507740
- Sponsor's protocol ID
- Praemarker AAT 08
- Status last verified
- Apr 2015
- First submitted
- 18 Sep 2009
- Last updated
- 29 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Profile of Soluble and Cellular Biomarkers and of Functional Imaging During Antiangiogenic Therapies in Cancer Patients
- ClinicalTrials.gov ID
- NCT01507740
- Acronym / sponsor ID
- Praemarker AAT 08
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study was stopped 04.10.2014 prematurly after recruitment of HCC and RCC patients. NSCLC (2 of 10 patients planned) and CRC patients recruitment was stopped
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 11 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Control group n=20 |
| 2 | – | Drug: Avastin, Drug: Suntent, Drug: Nexavarinvestigational group (cancer patients) n=40 patients treated with antiangiogenic agent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AvastinDosage, duration, indications and contraindications of treatment rely on the sole responsibility of the treating physician and are not subject of the present study | Drug | 2 |
| SuntentDosage, duration, indications and contraindications of treatment rely on the sole responsibility of the treating physician and are not subject of the present study | Drug | 2 |
| NexavarDosage, duration, indications and contraindications of treatment rely on the sole responsibility of the treating physician and are not subject of the present study | Drug | 2 |
Primary outcome
Progression free survival under antiangiogenic therapy
Time frame: progression of disease, up to 48 months
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
Results and safety
The study was stopped early (reason given: Study was stopped 04.10.2014 prematurly after recruitment of HCC and RCC patients. NSCLC (2 of 10 patients planned) and CRC patients recruitment was stopped). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2015.
Related trials for Hepatocellular Cancer
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
Lung Cancer, Hepatocellular Carcinoma
Recruiting
CREO - Microwave Ablation Feasibility Study
Pancreatic Cancer, Liver Cancer (Locally Advanced or Metastatic)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wolfgang Hilbe, Prof principal investigator
Medical University Innsbruck
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Cancer and Non-small Cell Lung Cancer, run by Medical University Innsbruck at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study was stopped 04.10.2014 prematurly after recruitment of HCC and RCC patients. NSCLC (2 of 10 patients planned) and CRC patients recruitment was stopped). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival under antiangiogenic therapy (time frame: progression of disease, up to 48 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2015.