Erlotinib Versus Carboplatin/Vinorelbine in Elderly Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) (TIE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Hospital Grosshansdorf.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hospital Grosshansdorf
ClinicalTrials.gov Identifier:
NCT00678964
First received: May 14, 2008
Last updated: May 15, 2008
Last verified: May 2008
  Purpose

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.


Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: Erlotinib
Drug: Vinorelbine and Carboplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicentre Randomised Phase II Trial of Erlotinib Versus Carboplatin/Vinorelbine in Elderly Patients (=/> 70 Years) With Advanced Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Hospital Grosshansdorf:

Primary Outcome Measures:
  • Evaluation of the progression free survival rate with the first-line therapy [ Time Frame: Tumour assessment every other cycle (interval of 42 days) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of remission [ Time Frame: Tumour assessment every other cycle (interval of 42 days) ] [ Designated as safety issue: No ]
  • 1-year survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: End of study ] [ Designated as safety issue: No ]
  • Response rate (CR/RR) [ Time Frame: Tumour assessment every other cycle (interval of 42 days) ] [ Designated as safety issue: No ]
  • Quality of life, improvement of symptoms (FACT-L) [ Time Frame: Every other cycle (interval of 42 days) ] [ Designated as safety issue: No ]
  • Simplified Charlsons´Comorbidity Score [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Safety and Tolerability [ Time Frame: continously ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 260
Study Start Date: June 2006
Estimated Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: Erlotinib
Erlotinib 150 mg, p.o., once daily
Other Name: Tarceva
Active Comparator: B Drug: 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 Names:
  • Navelbine
  • Carboplat

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00678964

Locations
Germany
Gemeinschaftspraxis Recruiting
Augsburg, Germany, 86150
Contact: Heinrich, Dr.    +41 821 344650      
Principal Investigator: Heinrich, Dr.         
Zentralklinik Bad Berka GmbH Recruiting
Bad Berka, Germany, 99437
Contact: Bonnet, Dr.    +41 36458 51500      
Principal Investigator: Bonnet, Dr.         
Helios Klinikum Emil von Behring Recruiting
Berlin, Germany, 14165
Contact: Monika Serke, Dr.    +41 30 80022304      
Principal Investigator: Monika Serke, Dr.         
Evangelische Lungenklinik Berlin Recruiting
Berlin, Germany
Contact: Sylke Kurz, Dr.    +41 30 94802112      
Principal Investigator: Sylke Kurz, Dr.         
Charité - Campus Benjamin Franklin Recruiting
Berlin, Germany, 12200
Contact: Alexander Schmittel, Dr.    +41 30 84453090      
Principal Investigator: Alexander Schmittel, Dr.         
Evang. Krankenhaus Bielefeld Recruiting
Bielefeld, Germany, 33611
Contact: Meinolf Karthaus, Prof. Dr.    +41 521 77275504      
Principal Investigator: Meinolf Karthaus, Prof. dr.         
Johanniter-Krankenhaus Bonn Recruiting
Bonn, Germany, 53113
Contact: Yon-Dschun Ko, Prof. Dr.    +41 228 5432202      
Principal Investigator: Yon-Dschun Ko, Prof. Dr.         
Gemeinschaftspraxis Recruiting
Celle, Germany, 29221
Contact: Raack, Dr.    +41 5141 9929490      
Principal Investigator: Raack, Dr.         
Fachkrankenhaus Coswig Recruiting
Coswig, Germany, 01640
Contact: Gerd Höffken, Prof. Dr.    +41 3523 65-0      
Principal Investigator: Gerd Höffken, Prof. Dr.         
Fachklinik Diekholzen Recruiting
Diekholzen, Germany, 31199
Contact: Wolfram Meister, Dr.    +41 5121 201383      
Principal Investigator: Wolfram Meister, Dr.         
Klinikum Donaustauf Recruiting
Donaustauf, Germany, 93093
Contact: Norbert Meidenbauer, Dr.    +41 9403 800      
Principal Investigator: Norbert Meidenbauer, Dr.         
Katholisches Klinikum Duisburg Recruiting
Duisburg, Germany, 47166
Contact: Michael Schroeder, Dr.    +41 203 5462482      
Principal Investigator: Michael Schroeder, Dr.         
Marien Hospital Düsseldorf Recruiting
Düsseldorf, Germany, 40479
Contact: Schütte, Prof. Dr.    +41 211 44002501      
Principal Investigator: Schütte, Prof. Dr.         
Universitätsklinik Essen Recruiting
Essen, Germany, 45122
Contact: Eberhardt, Dr.    +41 201 723-2168      
Principal Investigator: Eberhardt, Dr.         
Klinikum Essen-Mitte Recruiting
Essen, Germany, 45136
Contact: Koester, Prof. Dr.    +41 201 1741251      
Principal Investigator: Koester, Prof. Dr.         
Krankenhaus Nordwest GmbH Recruiting
Frankfurt/Main, Germany, 60488
Contact: Elke Jäger, Prof. Dr.    +41 69 76013340      
Principal Investigator: Elke Jäger, Prof. Dr.         
Asklepios Fachkliniken München-Gauting Recruiting
Gauting, Germany, 82131
Contact: von Pawel, Dr.    +41 89 857912011      
Principal Investigator: von Pawel, Dr.         
Schwerpunktpraxis Onkologie Recruiting
Goslar, Germany, 38642
Contact: Tessen, Dr.    +41 5321 686102      
Principal Investigator: Tessen, Dr.         
Universitätsklinikum der Ernst-Moritz Arndt Universität Greifswald Recruiting
Greifswald, Germany, 17475
Contact: Ralf Ewert, Prof. Dr.    +41 3834 866776      
Principal Investigator: Ralf Ewert, Prof. Dr.         
Krankenhaus Großhansdorf Recruiting
Großhansdorf, Germany, 22927
Contact: Martin Reck, Dr.    +41 4102 601188      
Principal Investigator: Martin Reck, Dr.         
Georg-August-Universität Göttingen Recruiting
Göttingen, Germany, 37075
Contact: Schüttrumpf, Dr.    +41 551 398538      
Principal Investigator: Schüttrumpf, Dr.         
Allgemeines Krankenhaus Harburg Recruiting
Hamburg, Germany, 21075
Contact: Kaukel, Prof. Dr.    +41 40 1818860      
Principal Investigator: Kaukel, Prof. Dr.         
Medizinische Hochschule Hannover Recruiting
Hannover, Germany, 30625
Contact: Nicolas Dickgreber, Dr.    +41 511 5323934      
Principal Investigator: Nicolas Dickgreber, Dr.         
Thoraxklinik am Universitätsklinikum Heidelberg Recruiting
Heidelberg, Germany, 69126
Contact: Michael Thomas, Prof. Dr.    +41 6221 3961300      
Principal Investigator: Michael Thomas, Prof. Dr.         
Lungenklinik Hemer Recruiting
Hemer, Germany, 58675
Contact: Lutz Freitag, Dr.    +41 2372 9082201      
Principal Investigator: Lutz Freitag, Dr.         
Universitätsklinik des Saarlandes Recruiting
Homburg/Saar, Germany, 66421
Contact: Andreas Göschel, Dr.    +41 8641 1623614      
Principal Investigator: Andreas Göschel, Dr.         
Klinikum der Friedrich-Schiller-Universität Recruiting
Jena, Germany, 07740
Contact: Angelika Reißig, Dr.    +41 3641 9329131      
Principal Investigator: Angelika Reißig, Dr.         
Klinikum Kassel Recruiting
Kassel, Germany, 34125
Contact: Martin Wolf, Prof. Dr.    +41 561 9803045      
Principal Investigator: Martin Wolf, Prof. Dr.         
Malteser Krankenhaus St. Hildegardis Köln Recruiting
Köln, Germany, 50931
Contact: Michael von Eiff, Prof. Dr.    +41 221 4003231      
Principal Investigator: Michael von Eiff, Prof. Dr.         
Klinikum Leverkusen gGmbH Recruiting
Leverkusen, Germany, 51375
Contact: Niederle, Prof. Dr.    +41 214 132672      
Principal Investigator: Niederle, Prof. Dr.         
Klinik Löwenstein gGmbH Recruiting
Loewenstein, Germany, 74245
Contact: Fischer, Dr.    +41 7130 15-0      
Principal Investigator: Fischer, Dr.         
Universitätsklinikum Schleswig-Holstein Recruiting
Lübeck, Germany, 23538
Contact: Dalhoff, Prof. Dr.    +41 451 5002375      
Principal Investigator: Dalhoff, Prof. Dr.         
Klinikum der Johannes Gutenberg-Universität Mainz Recruiting
Mainz, Germany, 55131
Contact: Fischer, Dr.    +41 6131 177135      
Principal Investigator: Fischer, Dr.         
Katholisches Klinikum Mainz Recruiting
Mainz, Germany, 55131
Contact: Kortsik, Prof. Dr.    +41 6131 147412      
Principal Investigator: Kortsik, Prof. Dr.         
Universitätsklinikum Mannheim gGmbH Recruiting
Mannheim, Germany, 68167
Contact: Dieter Buchheidt, Dr.    +41 621 3834110      
Principal Investigator: Dieter Buchheidt, Dr.         
Zweckverband Kliniken im Mühlenkreis Recruiting
Minden, Germany, 32423
Contact: Bodenstein, Prof. Dr.    +41 571 801-4810      
Principal Investigator: Bodenstein, Prof. Dr.         
Medizinische Klinik - Innenstadt Recruiting
München, Germany, 80336
Contact: Huber, Prof. Dr.    +41 89 51602590      
Principal Investigator: Huber, Prof. Dr.         
Ruppiner Kliniken GmbH Recruiting
Neuruppin, Germany, 16816
Contact: Deppermann, Dr.    +49 3391 393112      
Principal Investigator: Deppermann, Dr.         
Johanniter-Krankenhaus im Fläming gGmbH Recruiting
Treuenbrietzen, Germany, 14929
Contact: Steffi Mai, Dr.    +41 33748 82441      
Principal Investigator: Steffi Mai, Dr.         
Universitätsklinikum Ulm Recruiting
Ulm, Germany, 89081
Contact: Stefan Schumann, Dr.    +41 731 50024453      
Principal Investigator: Stefan Krüger, Dr.         
Sponsors and Collaborators
Hospital Grosshansdorf
Investigators
Principal Investigator: Martin Reck, Dr. Hospital Grosshansdorf
  More Information

No publications provided

Responsible Party: Dr. Martin Reck, Hospital Grosshansdorf
ClinicalTrials.gov Identifier: NCT00678964     History of Changes
Other Study ID Numbers: EudraCT 2005-005827-32, ML19747
Study First Received: May 14, 2008
Last Updated: May 15, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Hospital Grosshansdorf:
NSCLC
Elderly patients

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Vinorelbine
Vinblastine
Carboplatin
Erlotinib
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 27, 2014