Erlotinib Versus Carboplatin/Vinorelbine in Elderly Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
- Conditions
- Non-Small Cell Lung Cancer
- Interventions
- Registration Number
- NCT00678964
- Lead Sponsor
- LungenClinic Grosshansdorf
- Brief Summary
60% of all malignant diseases occur in patients who are 65 years or older. For these patients, aggressive treatments are often not suitable due to reduced life-expectancy, reduced general condition, comorbidities, and reduced vital functions which can lead to increased adverse effects of chemotherapy. Therefore, it is important to investigate alternative therapy options for elderly patients.
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 260
- Histologically or cytological proven NSCLC, stage lll b (with pleural effusion) or stage lV.
- 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
- Uncontrolled metastasis in the CNS
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A Erlotinib - B Vinorelbine and Carboplatin -
- Primary Outcome Measures
Name Time Method Evaluation of the progression free survival rate with the first-line therapy Tumour assessment every other cycle (interval of 42 days)
- Secondary Outcome Measures
Name Time Method Duration of remission Tumour assessment every other cycle (interval of 42 days) 1-year survival 1 year Overall survival End of study Response rate (CR/RR) Tumour assessment every other cycle (interval of 42 days) Quality of life, improvement of symptoms (FACT-L) Every other cycle (interval of 42 days) Simplified Charlsons´Comorbidity Score baseline Safety and Tolerability continously
Trial Locations
- Locations (39)
Fachkrankenhaus Coswig
🇩🇪Coswig, Germany
Schwerpunktpraxis Onkologie
🇩🇪Goslar, Germany
Fachklinik Diekholzen
🇩🇪Diekholzen, Germany
Klinikum Donaustauf
🇩🇪Donaustauf, Germany
Gemeinschaftspraxis
🇩🇪Celle, Germany
Marien Hospital Düsseldorf
🇩🇪Düsseldorf, Germany
Universitätsklinik Essen
🇩🇪Essen, Germany
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Katholisches Klinikum Mainz
🇩🇪Mainz, Germany
Lungenklinik Hemer
🇩🇪Hemer, Germany
Klinik Löwenstein gGmbH
🇩🇪Loewenstein, Germany
Zweckverband Kliniken im Mühlenkreis
🇩🇪Minden, Germany
Klinikum der Johannes Gutenberg-Universität Mainz
🇩🇪Mainz, Germany
Universitätsklinikum Mannheim gGmbH
🇩🇪Mannheim, Germany
Katholisches Klinikum Duisburg
🇩🇪Duisburg, Germany
Klinikum Kassel
🇩🇪Kassel, Germany
Asklepios Fachkliniken München-Gauting
🇩🇪Gauting, Germany
Thoraxklinik am Universitätsklinikum Heidelberg
🇩🇪Heidelberg, Germany
Universitätsklinikum Schleswig-Holstein
🇩🇪Lübeck, Germany
Johanniter-Krankenhaus im Fläming gGmbH
🇩🇪Treuenbrietzen, Germany
Evang. Krankenhaus Bielefeld
🇩🇪Bielefeld, Germany
Klinikum Essen-Mitte
🇩🇪Essen, Germany
Allgemeines Krankenhaus Harburg
🇩🇪Hamburg, Germany
Klinikum Leverkusen gGmbH
🇩🇪Leverkusen, Germany
Ruppiner Kliniken GmbH
🇩🇪Neuruppin, Germany
Krankenhaus Großhansdorf
🇩🇪Großhansdorf, Germany
Universitätsklinik des Saarlandes
🇩🇪Homburg/Saar, Germany
Helios Klinikum Emil von Behring
🇩🇪Berlin, Germany
Charité - Campus Benjamin Franklin
🇩🇪Berlin, Germany
Evangelische Lungenklinik Berlin
🇩🇪Berlin, Germany
Zentralklinik Bad Berka GmbH
🇩🇪Bad Berka, Germany
Johanniter-Krankenhaus Bonn
🇩🇪Bonn, Germany
Krankenhaus Nordwest GmbH
🇩🇪Frankfurt/Main, Germany
Malteser Krankenhaus St. Hildegardis Köln
🇩🇪Köln, Germany
Universitätsklinikum der Ernst-Moritz Arndt Universität Greifswald
🇩🇪Greifswald, Germany
Klinikum der Friedrich-Schiller-Universität
🇩🇪Jena, Germany
Medizinische Klinik - Innenstadt
🇩🇪München, Germany
Universitätsklinikum Ulm
🇩🇪Ulm, Germany
Georg-August-Universität Göttingen
🇩🇪Göttingen, Germany