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Sponsored by: |
Lung Cancer Group Cologne |
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Information provided by: | Lung Cancer Group Cologne |
ClinicalTrials.gov Identifier: | NCT00568841 |
This is a Phase-II Study to evaluate the accuracy of Fluorodeoxyglucose-/Fluorothymidine-Positron Emission Tomography (FDG-/FLT-PET) analyses for early prediction of non-progression in patients with non-small-cell lung cancer (NSCLC) treated with Erlotinib.
Condition | Intervention | Phase |
---|---|---|
Carcinoma, Non-Small-Cell Lung |
Drug: erlotinib Procedure: FDG-/FLT-PET |
Phase II |
Study Type: | Interventional |
Study Design: | Diagnostic, Open Label, Single Group Assignment |
Official Title: | A Phase-II Clinical Trial to Evaluate the Accuracy of FDG-/FLT-PET for Early Prediction of Non-Progression in Patients With Advanced NSCLC Treated With Erlotinib and to Associate PET Findings With Molecular Markers |
Estimated Enrollment: | 40 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | January 2009 |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: erlotinib
erlotinib p.o. (by mouth), 150 mg once daily for week 1-6 (day 1-42)
Procedure: FDG-/FLT-PET
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Juergen Wolf, Prof., Dr. | 004922147889050 | juergen.wolf@uk-koeln.de |
Contact: Matthias Scheffler, MD | 004922147888796 | matthias.scheffler@uk-koeln.de |
Germany | |
Center for Integrated Oncology, University Hospital Cologne, Department I of Internal Medicine, Kerpenerstr.62 | Recruiting |
Cologne, Germany, 50924 | |
Contact: Juergen Wolf, Prof., Dr. 004922147889050 juergen.wolf@uk-koeln.de | |
Contact: Matthias Scheffler, MD 004922147888796 matthias.scheffler@uk-koeln.de | |
Principal Investigator: Juergen Wolf, Prof., Dr. | |
Sub-Investigator: Matthias Scheffler, MD | |
Sub-Investigator: Thomas Zander, MD | |
Sub-Investigator: Lucia Nogova, MD | |
Sub-Investigator: Karin Toepelt, MD | |
Sub-Investigator: Andreas Draube, MD |
Principal Investigator: | Juergen Wolf, Prof., Dr. | University Cologne, Lung Cancer Group Cologne |
Responsible Party: | University Cologne ( Prof. Dr. Juergen Wolf ) |
Study ID Numbers: | 2005-005393-73, 06159 |
Study First Received: | December 5, 2007 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00568841 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
advanced Non-Small-Cell Lung Cancer erlotinib FDG-PET FLT-PET |
Erlotinib Thoracic Neoplasms Signs and Symptoms Non-small cell lung cancer Respiratory Tract Diseases |
Lung Neoplasms Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type |
Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |