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

NCT00568841 | Unknown Phase 2 DMC

• 2 other identifiers: 2005-005393-7306159
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  34 months

Secondary Outcomes (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

  34 months

Study Arms (1)

1

EXPERIMENTAL

Drug: erlotinib; Procedure: FDG-/FLT-PET

Interventions

erlotinib DRUG

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

1

FDG-/FLT-PET PROCEDURE

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lung Cancer Group Cologne: lead

Study Sites (1)

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

Cologne, 50924, Germany

Location

Related Publications (28)

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• van Tinteren H, Hoekstra OS, Smit EF, van den Bergh JH, Schreurs AJ, Stallaert RA, van Velthoven PC, Comans EF, Diepenhorst FW, Verboom P, van Mourik JC, Postmus PE, Boers M, Teule GJ. Effectiveness of positron emission tomography in the preoperative assessment of patients with suspected non-small-cell lung cancer: the PLUS multicentre randomised trial. Lancet. 2002 Apr 20;359(9315):1388-93. doi: 10.1016/s0140-6736(02)08352-6.

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• Suleiman AA, Frechen S, Scheffler M, Zander T, Kahraman D, Kobe C, Wolf J, Nogova L, Fuhr U. Modeling tumor dynamics and overall survival in advanced non-small-cell lung cancer treated with erlotinib. J Thorac Oncol. 2015 Jan;10(1):84-92. doi: 10.1097/JTO.0000000000000330.

  PMID: 25226426 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.

  PMID: 23308140 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Juergen Wolf, Prof., Dr.

  University Cologne, Lung Cancer Group Cologne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 5, 2007
• First Posted: December 6, 2007
• Study Start: October 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: September 17, 2009

Record last verified: 2009-09

Locations

DE (1)