Erlotinib Versus Carboplatin/Vinorelbine in Elderly Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
NCT ID: NCT00678964
Last Updated: 2008-05-16
Study Results
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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UNKNOWN
PHASE2
260 participants
INTERVENTIONAL
2006-06-30
Brief Summary
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Erlotinib is an orally applied medication which is associated with reasonable toxicity. This targeted agent may prove an effective and well-tolerated first-line therapy in elderly patients with advanced non small cell lung cancer.
Therefore, the aim of this study is to investigate the progression-free survival of the combination of vinorelbine and carboplatin in comparison to erlotinib. Given that there will be no significant reduction of efficiency this may provide elderly patients of more than 70 years of age with an active oral substance without subjecting them to the sometimes severe adverse effect of the chemotherapy.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A
Erlotinib
Erlotinib 150 mg, p.o., once daily
B
Vinorelbine and Carboplatin
Vinorelbine 25 mg/m2, i.v., day 1 and 8 of every cycle (21 days) plus carboplatin AUC 5, i.v., day 1 of every cycle
Interventions
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Erlotinib
Erlotinib 150 mg, p.o., once daily
Vinorelbine and Carboplatin
Vinorelbine 25 mg/m2, i.v., day 1 and 8 of every cycle (21 days) plus carboplatin AUC 5, i.v., day 1 of every cycle
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Tumour is locally advanced and not suitable for surgery and radiotherapy is not indicated.
* Neither cytostatic nor immunological pre-treatment
* Age \>70 years
* At least one measurable lesion (RECIST criteria) that was not previously irradiated
* ECOG Performance Status 0-1
* Life expectancy \> 3 month
* Adequate bone marrow function: ANC \> 1.5 x 109/L, Platelets \> 100 x 109/L
* Adequate liver function: Total Bilirubin \< 1.5 x ULN, GOT/GPT\< 3 x ULN (existent liver metastases \< 5 x ULN)
* Adequate renal function:creatinine clearance \> 45 ml/min (calculated according to Cockroft-Gault)
* Fertile men must agree to use an effective method of birth control while participating in this study
* Signed written informed consent
Exclusion Criteria
* Acute, heavy uncontrolled infection
* Any other serious concomitant disease or medical condition, which could interfere with participating in this study
* Severe hypersensitivity to Erlotinib or any other component
* Hypersensitivity to Carboplatin and/or other platinum compounds
* Hypersensitivity to Vinorelbin or other Vinca-alkaloids
* Patients with a history of other active malignancy in the past 5 years (with the exception of carcinoma in situ of the cervix, non melanomatous skin cancers or local prostate carcinoma that was surgically treated successfully) are excluded.
* Participation in another clinical trial with any investigational drug at the same time or within 30 days prior to registration
* Psychological, familial, social or geographical situations limiting the compliance with the study requirements
70 Years
ALL
No
Sponsors
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LungenClinic Grosshansdorf
OTHER
Responsible Party
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Hospital Grosshansdorf
Principal Investigators
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Martin Reck, Dr.
Role: PRINCIPAL_INVESTIGATOR
LungenClinic Grosshansdorf
Locations
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Gemeinschaftspraxis
Augsburg, , Germany
Zentralklinik Bad Berka GmbH
Bad Berka, , Germany
Charité - Campus Benjamin Franklin
Berlin, , Germany
Helios Klinikum Emil von Behring
Berlin, , Germany
Evangelische Lungenklinik Berlin
Berlin, , Germany
Evang. Krankenhaus Bielefeld
Bielefeld, , Germany
Johanniter-Krankenhaus Bonn
Bonn, , Germany
Gemeinschaftspraxis
Celle, , Germany
Malteser Krankenhaus St. Hildegardis Köln
Cologne, , Germany
Fachkrankenhaus Coswig
Coswig, , Germany
Fachklinik Diekholzen
Diekholzen, , Germany
Klinikum Donaustauf
Donaustauf, , Germany
Katholisches Klinikum Duisburg
Duisburg, , Germany
Marien Hospital Düsseldorf
Düsseldorf, , Germany
Universitätsklinik Essen
Essen, , Germany
Klinikum Essen-Mitte
Essen, , Germany
Krankenhaus Nordwest GmbH
Frankfurt am Main, , Germany
Asklepios Fachkliniken München-Gauting
Gauting, , Germany
Schwerpunktpraxis Onkologie
Goslar, , Germany
Georg-August-Universität Göttingen
Göttingen, , Germany
Universitätsklinikum der Ernst-Moritz Arndt Universität Greifswald
Greifswald, , Germany
Krankenhaus Großhansdorf
Großhansdorf, , Germany
Allgemeines Krankenhaus Harburg
Hamburg, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Thoraxklinik am Universitätsklinikum Heidelberg
Heidelberg, , Germany
Lungenklinik Hemer
Hemer, , Germany
Universitätsklinik des Saarlandes
Homburg/Saar, , Germany
Klinikum der Friedrich-Schiller-Universität
Jena, , Germany
Klinikum Kassel
Kassel, , Germany
Klinikum Leverkusen gGmbH
Leverkusen, , Germany
Klinik Löwenstein gGmbH
Löwenstein, , Germany
Universitätsklinikum Schleswig-Holstein
Lübeck, , Germany
Katholisches Klinikum Mainz
Mainz, , Germany
Klinikum der Johannes Gutenberg-Universität Mainz
Mainz, , Germany
Universitätsklinikum Mannheim gGmbH
Mannheim, , Germany
Zweckverband Kliniken im Mühlenkreis
Minden, , Germany
Medizinische Klinik - Innenstadt
München, , Germany
Ruppiner Kliniken GmbH
Neuruppin, , Germany
Johanniter-Krankenhaus im Fläming gGmbH
Treuenbrietzen, , Germany
Universitätsklinikum Ulm
Ulm, , Germany
Countries
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Facility Contacts
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Heinrich, Dr.
Role: primary
Bonnet, Dr.
Role: primary
Alexander Schmittel, Dr.
Role: primary
Monika Serke, Dr.
Role: primary
Sylke Kurz, Dr.
Role: primary
Meinolf Karthaus, Prof. Dr.
Role: primary
Yon-Dschun Ko, Prof. Dr.
Role: primary
Raack, Dr.
Role: primary
Michael von Eiff, Prof. Dr.
Role: primary
Gerd Höffken, Prof. Dr.
Role: primary
Wolfram Meister, Dr.
Role: primary
Norbert Meidenbauer, Dr.
Role: primary
Michael Schroeder, Dr.
Role: primary
Schütte, Prof. Dr.
Role: primary
Eberhardt, Dr.
Role: primary
Koester, Prof. Dr.
Role: primary
Elke Jäger, Prof. Dr.
Role: primary
von Pawel, Dr.
Role: primary
Tessen, Dr.
Role: primary
Schüttrumpf, Dr.
Role: primary
Ralf Ewert, Prof. Dr.
Role: primary
Martin Reck, Dr.
Role: primary
Kaukel, Prof. Dr.
Role: primary
Nicolas Dickgreber, Dr.
Role: primary
Michael Thomas, Prof. Dr.
Role: primary
Lutz Freitag, Dr.
Role: primary
Andreas Göschel, Dr.
Role: primary
Angelika Reißig, Dr.
Role: primary
Martin Wolf, Prof. Dr.
Role: primary
Niederle, Prof. Dr.
Role: primary
Fischer, Dr.
Role: primary
Dalhoff, Prof. Dr.
Role: primary
Kortsik, Prof. Dr.
Role: primary
Fischer, Dr.
Role: primary
Dieter Buchheidt, Dr.
Role: primary
Bodenstein, Prof. Dr.
Role: primary
Huber, Prof. Dr.
Role: primary
Deppermann, Dr.
Role: primary
Steffi Mai, Dr.
Role: primary
Stefan Schumann, Dr.
Role: primary
Other Identifiers
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ML19747
Identifier Type: -
Identifier Source: secondary_id
EudraCT 2005-005827-32
Identifier Type: -
Identifier Source: org_study_id
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