Clinical trial NCT00678964: Erlotinib Versus Carboplatin/Vinorelbine in Elderly Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
Official title: Multicentre Randomised Phase II Trial of Erlotinib Versus Carboplatin/Vinorelbine in Elderly Patients (=/> 70 Years) With Advanced Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Non-Small Cell Lung Cancer
Keywords: NSCLC
Elderly patients
Lead sponsor: LungenClinic Grosshansdorf
Sponsor class: OTHER
First posted: 2008-05-16
Enrollment: 260
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Evaluation of the progression free survival rate with the first-line therapy
timeFrame: Tumour assessment every other cycle (interval of 42 days)
Secondary outcomes:
measure: Duration of remission
timeFrame: Tumour assessment every other cycle (interval of 42 days)
measure: 1-year survival
timeFrame: 1 year
measure: Overall survival
timeFrame: End of study
measure: Response rate (CR/RR)
timeFrame: Tumour assessment every other cycle (interval of 42 days)
measure: Quality of life, improvement of symptoms (FACT-L)
timeFrame: Every other cycle (interval of 42 days)
measure: Simplified Charlsons´Comorbidity Score
timeFrame: baseline
measure: Safety and Tolerability
timeFrame: continously
Other outcomes:
Locations:
city: Augsburg
country: Germany
facility: Gemeinschaftspraxis
city: Bad Berka
country: Germany
facility: Zentralklinik Bad Berka GmbH
city: Berlin
country: Germany
facility: Charité - Campus Benjamin Franklin
city: Berlin
country: Germany
facility: Helios Klinikum Emil von Behring
city: Berlin
country: Germany
facility: Evangelische Lungenklinik Berlin
city: Bielefeld
country: Germany
facility: Evang. Krankenhaus Bielefeld
city: Bonn
country: Germany
facility: Johanniter-Krankenhaus Bonn
city: Celle
country: Germany
facility: Gemeinschaftspraxis
city: Coswig
country: Germany
facility: Fachkrankenhaus Coswig
city: Diekholzen
country: Germany
facility: Fachklinik Diekholzen
city: Donaustauf
country: Germany
facility: Klinikum Donaustauf
city: Duisburg
country: Germany
facility: Katholisches Klinikum Duisburg
city: Düsseldorf
country: Germany
facility: Marien Hospital Düsseldorf
city: Essen
country: Germany
facility: Universitätsklinik Essen
city: Essen
country: Germany
facility: Klinikum Essen-Mitte
city: Frankfurt/Main
country: Germany
facility: Krankenhaus Nordwest GmbH
city: Gauting
country: Germany
facility: Asklepios Fachkliniken München-Gauting
city: Goslar
country: Germany
facility: Schwerpunktpraxis Onkologie
city: Greifswald
country: Germany
facility: Universitätsklinikum der Ernst-Moritz Arndt Universität Greifswald
city: Großhansdorf
country: Germany
facility: Krankenhaus Großhansdorf
city: Göttingen
country: Germany
facility: Georg-August-Universität Göttingen
city: Hamburg
country: Germany
facility: Allgemeines Krankenhaus Harburg
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Heidelberg
country: Germany
facility: Thoraxklinik am Universitätsklinikum Heidelberg
city: Hemer
country: Germany
facility: Lungenklinik Hemer
city: Homburg/Saar
country: Germany
facility: Universitätsklinik des Saarlandes
city: Jena
country: Germany
facility: Klinikum der Friedrich-Schiller-Universität
city: Kassel
country: Germany
facility: Klinikum Kassel
city: Köln
country: Germany
facility: Malteser Krankenhaus St. Hildegardis Köln
city: Leverkusen
country: Germany
facility: Klinikum Leverkusen gGmbH
city: Loewenstein
country: Germany
facility: Klinik Löwenstein gGmbH
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein
city: Mainz
country: Germany
facility: Katholisches Klinikum Mainz
city: Mainz
country: Germany
facility: Klinikum der Johannes Gutenberg-Universität Mainz
city: Mannheim
country: Germany
facility: Universitätsklinikum Mannheim gGmbH
city: Minden
country: Germany
facility: Zweckverband Kliniken im Mühlenkreis
city: München
country: Germany
facility: Medizinische Klinik - Innenstadt
city: Neuruppin
country: Germany
facility: Ruppiner Kliniken GmbH
city: Treuenbrietzen
country: Germany
facility: Johanniter-Krankenhaus im Fläming gGmbH
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
Study officials:
affiliation: LungenClinic Grosshansdorf
name: Martin Reck, Dr.
role: PRINCIPAL_INVESTIGATOR
References: