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

Primary Purpose

Carcinoma, Non-Small-Cell Lung

Status

Unknown status

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

erlotinib

FDG-/FLT-PET

About this trial

This is an interventional diagnostic trial for Carcinoma, Non-Small-Cell Lung focused on measuring advanced Non-Small-Cell Lung Cancer, erlotinib, FDG-PET, FLT-PET

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Center for Integrated Oncology, University Hospital Cologne, Department I of Internal Medicine, Kerpenerstr.62

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

To evaluate the accuracy of FDG-/FLT-PET analyses for early prediction of non-progression in patients with NSCLC treated with Erlotinib

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00568841

First Posted

December 5, 2007

Last Updated

September 16, 2009

Sponsor

Lung Cancer Group Cologne

1. Study Identification

Unique Protocol Identification Number

NCT00568841

Brief Title

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

Acronym

ERLOPET

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 Type

Interventional

2. Study Status

Record Verification Date

September 2009

Overall Recruitment Status

Unknown status

Study Start Date

October 2007 (undefined)

Primary Completion Date

December 2009 (Anticipated)

Study Completion Date

December 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Lung Cancer Group Cologne

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carcinoma, Non-Small-Cell Lung

Keywords

advanced Non-Small-Cell Lung Cancer, erlotinib, FDG-PET, FLT-PET

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

erlotinib

Intervention Description

erlotinib p.o. (by mouth), 150 mg once daily for week 1-6 (day 1-42)

Intervention Type

Procedure

Intervention Name(s)

FDG-/FLT-PET

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

Time Frame

34 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Juergen Wolf, Prof., Dr.

Organizational Affiliation

University Cologne, Lung Cancer Group Cologne

Official's Role

Principal Investigator

Facility Information:

Facility Name

Center for Integrated Oncology, University Hospital Cologne, Department I of Internal Medicine, Kerpenerstr.62

City

Cologne

ZIP/Postal Code

50924

Country

Germany

12. IPD Sharing Statement

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Links:

URL

http://www.cio-koeln.de

Description

website of the study location - Center for Integrated Oncology, University Hospital Cologne, Germany

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

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