Erlotinib and Sequential Positron Emission Tomography (PET) in Advanced Non Small Cell Lung Cancer (NSCLC)
NCT ID: NCT00568841
Last Updated: 2009-09-17
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
PHASE2
Total Enrollment
40 participants
Study Classification
INTERVENTIONAL
Study Start Date
2007-10-31
Study Completion Date
2009-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Carcinoma, Non-Small-Cell Lung
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
DIAGNOSTIC
Blinding Strategy
NONE
Study Groups
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1
Group Type
EXPERIMENTAL
erlotinib
Intervention Type
DRUG
erlotinib p.o. (by mouth), 150 mg once daily for week 1-6 (day 1-42)
FDG-/FLT-PET
Intervention Type
PROCEDURE
Interventions
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erlotinib
erlotinib p.o. (by mouth), 150 mg once daily for week 1-6 (day 1-42)
Intervention Type
DRUG
FDG-/FLT-PET
Intervention Type
PROCEDURE
Eligibility Criteria
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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
* ≥ 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
* 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
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Lung Cancer Group Cologne
OTHER
Sponsor Role
lead
Responsible Party
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University Cologne
Principal Investigators
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Juergen Wolf, Prof., Dr.
Role: PRINCIPAL_INVESTIGATOR
University Cologne, Lung Cancer Group Cologne
Locations
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Center for Integrated Oncology, University Hospital Cologne, Department I of Internal Medicine, Kerpenerstr.62
Cologne, , Germany
Site Status
Countries
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Germany
References
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Stroobants S, Goeminne J, Seegers M, Dimitrijevic S, Dupont P, Nuyts J, Martens M, van den Borne B, Cole P, Sciot R, Dumez H, Silberman S, Mortelmans L, van Oosterom A. 18FDG-Positron emission tomography for the early prediction of response in advanced soft tissue sarcoma treated with imatinib mesylate (Glivec). Eur J Cancer. 2003 Sep;39(14):2012-20. doi: 10.1016/s0959-8049(03)00073-x.
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DERIVED
Scheffler M, Zander T, Nogova L, Kobe C, Kahraman D, Dietlein M, Papachristou I, Heukamp L, Buttner R, Boellaard R, Lammertsma AA, Querings S, Stoelben E, Engel-Riedel W, Neumaier B, Wolf J. Prognostic impact of [18F]fluorothymidine and [18F]fluoro-D-glucose baseline uptakes in patients with lung cancer treated first-line with erlotinib. PLoS One. 2013;8(1):e53081. doi: 10.1371/journal.pone.0053081. Epub 2013 Jan 4.
Reference Type
DERIVED
Other Identifiers
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06159
Identifier Type: -
Identifier Source: secondary_id
2005-005393-73
Identifier Type: -
Identifier Source: org_study_id
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