Erlotinib Versus Carboplatin/Vinorelbine in Elderly Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
TIE
Multicentre Randomised Phase II Trial of Erlotinib Versus Carboplatin/Vinorelbine in Elderly Patients (=/> 70 Years) With Advanced Non-Small Cell Lung Cancer
2 other identifiers
interventional
260
1 country
40
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 nonsmall-cell-lung-cancer
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 14, 2008
CompletedFirst Posted
Study publicly available on registry
May 16, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2008
CompletedMay 16, 2008
May 1, 2008
2.4 years
May 14, 2008
May 15, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluation of the progression free survival rate with the first-line therapy
Tumour assessment every other cycle (interval of 42 days)
Secondary Outcomes (7)
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)
- +2 more secondary outcomes
Study Arms (2)
A
EXPERIMENTALB
ACTIVE COMPARATORInterventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (40)
Gemeinschaftspraxis
Augsburg, 86150, Germany
Zentralklinik Bad Berka GmbH
Bad Berka, 99437, Germany
Charité - Campus Benjamin Franklin
Berlin, 12200, Germany
Helios Klinikum Emil von Behring
Berlin, 14165, Germany
Evangelische Lungenklinik Berlin
Berlin, Germany
Evang. Krankenhaus Bielefeld
Bielefeld, 33611, Germany
Johanniter-Krankenhaus Bonn
Bonn, 53113, Germany
Gemeinschaftspraxis
Celle, 29221, Germany
Malteser Krankenhaus St. Hildegardis Köln
Cologne, 50931, Germany
Fachkrankenhaus Coswig
Coswig, 01640, Germany
Fachklinik Diekholzen
Diekholzen, 31199, Germany
Klinikum Donaustauf
Donaustauf, 93093, Germany
Katholisches Klinikum Duisburg
Duisburg, 47166, Germany
Marien Hospital Düsseldorf
Düsseldorf, 40479, Germany
Universitätsklinik Essen
Essen, 45122, Germany
Klinikum Essen-Mitte
Essen, 45136, Germany
Krankenhaus Nordwest GmbH
Frankfurt am Main, 60488, Germany
Asklepios Fachkliniken München-Gauting
Gauting, 82131, Germany
Schwerpunktpraxis Onkologie
Goslar, 38642, Germany
Georg-August-Universität Göttingen
Göttingen, 37075, Germany
Universitätsklinikum der Ernst-Moritz Arndt Universität Greifswald
Greifswald, 17475, Germany
Krankenhaus Großhansdorf
Großhansdorf, 22927, Germany
Allgemeines Krankenhaus Harburg
Hamburg, 21075, Germany
Medizinische Hochschule Hannover
Hanover, 30625, Germany
Thoraxklinik am Universitätsklinikum Heidelberg
Heidelberg, 69126, Germany
Lungenklinik Hemer
Hemer, 58675, Germany
Universitätsklinik des Saarlandes
Homburg/Saar, 66421, Germany
Klinikum der Friedrich-Schiller-Universität
Jena, 07740, Germany
Klinikum Kassel
Kassel, 34125, Germany
Klinikum Leverkusen gGmbH
Leverkusen, 51375, Germany
Klinik Löwenstein gGmbH
Löwenstein, 74245, Germany
Universitätsklinikum Schleswig-Holstein
Lübeck, 23538, Germany
Katholisches Klinikum Mainz
Mainz, 55131, Germany
Klinikum der Johannes Gutenberg-Universität Mainz
Mainz, 55131, Germany
Universitätsklinikum Mannheim gGmbH
Mannheim, 68167, Germany
Zweckverband Kliniken im Mühlenkreis
Minden, 32423, Germany
Medizinische Klinik - Innenstadt
München, 80336, Germany
Ruppiner Kliniken GmbH
Neuruppin, 16816, Germany
Johanniter-Krankenhaus im Fläming gGmbH
Treuenbrietzen, 14929, Germany
Universitätsklinikum Ulm
Ulm, 89081, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Martin Reck, Dr.
LungenClinic Grosshansdorf
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 14, 2008
First Posted
May 16, 2008
Study Start
June 1, 2006
Primary Completion
November 1, 2008
Last Updated
May 16, 2008
Record last verified: 2008-05