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

May 15, 2008 updated by: LungenClinic Grosshansdorf

Multicentre Randomised Phase II Trial of Erlotinib Versus Carboplatin/Vinorelbine in Elderly Patients (=/> 70 Years) With Advanced Non-Small Cell Lung Cancer

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

260

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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:
  • Carboplat
  • Navelbine
Experimental: A
Drug: Erlotinib
Erlotinib 150 mg, p.o., once daily
Other Names:
  • Tarceva

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluation of the progression free survival rate with the first-line therapy
Time Frame: Tumour assessment every other cycle (interval of 42 days)
Tumour assessment every other cycle (interval of 42 days)

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: End of study
End of study
Duration of remission
Time Frame: Tumour assessment every other cycle (interval of 42 days)
Tumour assessment every other cycle (interval of 42 days)
1-year survival
Time Frame: 1 year
1 year
Response rate (CR/RR)
Time Frame: Tumour assessment every other cycle (interval of 42 days)
Tumour assessment every other cycle (interval of 42 days)
Quality of life, improvement of symptoms (FACT-L)
Time Frame: Every other cycle (interval of 42 days)
Every other cycle (interval of 42 days)
Simplified Charlsons´Comorbidity Score
Time Frame: baseline
baseline
Safety and Tolerability
Time Frame: continously
continously

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LungenClinic Grosshansdorf

Investigators

  • Principal Investigator: Martin Reck, Dr., LungenClinic Grosshansdorf

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Anticipated)

November 1, 2008

Study Registration Dates

First Submitted

May 14, 2008

First Submitted That Met QC Criteria

May 15, 2008

First Posted (Estimate)

May 16, 2008

Study Record Updates

Last Update Posted (Estimate)

May 16, 2008

Last Update Submitted That Met QC Criteria

May 15, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EudraCT 2005-005827-32
  • ML19747

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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