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Erlotinib and Sequential Positron Emission Tomography (PET) in Advanced Non Small Cell Lung Cancer (NSCLC) (ERLOPET)

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ClinicalTrials.gov Identifier: NCT00568841
Recruitment Status : Unknown
Verified September 2009 by Lung Cancer Group Cologne.
Recruitment status was:  Active, not recruiting
First Posted : December 6, 2007
Last Update Posted : September 17, 2009
Sponsor:
Information provided by:
Lung Cancer Group Cologne

Brief Summary:
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 or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: erlotinib Procedure: FDG-/FLT-PET Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Study Start Date : October 2007
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: erlotinib
erlotinib p.o. (by mouth), 150 mg once daily for week 1-6 (day 1-42)
Procedure: FDG-/FLT-PET



Primary Outcome Measures :
  1. To evaluate the accuracy of FDG-/FLT-PET analyses for early prediction of non-progression in patients with NSCLC treated with Erlotinib [ Time Frame: 34 months ]

Secondary Outcome Measures :
  1. To identify PET characteristics for progression, response and stable disease; To identify EGFR and KRAS sequence characteristics for clinical response and stable disease; Safety; Response rates; One-year FFTF; One-year OS; Median overall survival time [ Time Frame: 34 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent
  • ≥ 18 years of age
  • Untreated non-small-cell lung cancer stage IIIB/IV
  • Life expectancy > 3 months
  • Performance status ECOG 0-2

Exclusion Criteria:

  • Concurrent systemic immune therapy, chemotherapy or therapy with any anticancer drug not indicated in the study protocol
  • Any investigational agent(s) within 4 weeks prior to study entry
  • Previous administration of any EGFR-targeted therapy (antibodies, small molecules and others)
  • Any medical, mental or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or understand the patient information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00568841


Locations
Germany
Center for Integrated Oncology, University Hospital Cologne, Department I of Internal Medicine, Kerpenerstr.62
Cologne, Germany, 50924
Sponsors and Collaborators
Lung Cancer Group Cologne
Investigators
Principal Investigator: Juergen Wolf, Prof., Dr. University Cologne, Lung Cancer Group Cologne

Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Dr. Juergen Wolf, University Cologne
ClinicalTrials.gov Identifier: NCT00568841     History of Changes
Other Study ID Numbers: 2005-005393-73
06159
First Posted: December 6, 2007    Key Record Dates
Last Update Posted: September 17, 2009
Last Verified: September 2009

Keywords provided by Lung Cancer Group Cologne:
advanced Non-Small-Cell Lung Cancer
erlotinib
FDG-PET
FLT-PET

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action