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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Lung Cancer Group Cologne.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Lung Cancer Group Cologne
ClinicalTrials.gov Identifier:
NCT00568841
First received: December 5, 2007
Last updated: September 16, 2009
Last verified: September 2009

December 5, 2007
September 16, 2009
October 2007
December 2009   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00568841 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Erlotinib and Sequential Positron Emission Tomography (PET) in Advanced Non Small Cell Lung Cancer (NSCLC)
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

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.

Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Carcinoma, Non-Small-Cell Lung
  • Drug: erlotinib
    erlotinib p.o. (by mouth), 150 mg once daily for week 1-6 (day 1-42)
  • Procedure: FDG-/FLT-PET
Experimental: 1
Interventions:
  • Drug: erlotinib
  • Procedure: FDG-/FLT-PET

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
40
December 2009
December 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00568841
2005-005393-73, 06159
Yes
Prof. Dr. Juergen Wolf, University Cologne
Lung Cancer Group Cologne
Not Provided
Principal Investigator: Juergen Wolf, Prof., Dr. University Cologne, Lung Cancer Group Cologne
Lung Cancer Group Cologne
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP