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

Non-Small Cell Lung Cancer Clinical Trial

— TIE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00678964
• Other study ID #: EudraCT 2005-005827-32
• Secondary ID: ML19747
• Status: Recruiting
• Phase: Phase 2
• First received: May 14, 2008
• Last updated: May 15, 2008
• Start date: June 2006

Study information

• Verified date: May 2008
• Source: LungenClinic Grosshansdorf
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 260
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Drug:
• Erlotinib
Erlotinib 150 mg, p.o., once daily
• 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

Locations

Country	Name	City	State
Germany	Gemeinschaftspraxis	Augsburg
Germany	Zentralklinik Bad Berka GmbH	Bad Berka
Germany	Charité - Campus Benjamin Franklin	Berlin
Germany	Evangelische Lungenklinik Berlin	Berlin
Germany	Helios Klinikum Emil von Behring	Berlin
Germany	Evang. Krankenhaus Bielefeld	Bielefeld
Germany	Johanniter-Krankenhaus Bonn	Bonn
Germany	Gemeinschaftspraxis	Celle
Germany	Fachkrankenhaus Coswig	Coswig
Germany	Fachklinik Diekholzen	Diekholzen
Germany	Klinikum Donaustauf	Donaustauf
Germany	Katholisches Klinikum Duisburg	Duisburg
Germany	Marien Hospital Düsseldorf	Düsseldorf
Germany	Klinikum Essen-Mitte	Essen
Germany	Universitätsklinik Essen	Essen
Germany	Krankenhaus Nordwest GmbH	Frankfurt/Main
Germany	Asklepios Fachkliniken München-Gauting	Gauting
Germany	Schwerpunktpraxis Onkologie	Goslar
Germany	Georg-August-Universität Göttingen	Göttingen
Germany	Universitätsklinikum der Ernst-Moritz Arndt Universität Greifswald	Greifswald
Germany	Krankenhaus Großhansdorf	Großhansdorf
Germany	Allgemeines Krankenhaus Harburg	Hamburg
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Thoraxklinik am Universitätsklinikum Heidelberg	Heidelberg
Germany	Lungenklinik Hemer	Hemer
Germany	Universitätsklinik des Saarlandes	Homburg/Saar
Germany	Klinikum der Friedrich-Schiller-Universität	Jena
Germany	Klinikum Kassel	Kassel
Germany	Malteser Krankenhaus St. Hildegardis Köln	Köln
Germany	Klinikum Leverkusen gGmbH	Leverkusen
Germany	Klinik Löwenstein gGmbH	Loewenstein
Germany	Universitätsklinikum Schleswig-Holstein	Lübeck
Germany	Katholisches Klinikum Mainz	Mainz
Germany	Klinikum der Johannes Gutenberg-Universität Mainz	Mainz
Germany	Universitätsklinikum Mannheim gGmbH	Mannheim
Germany	Zweckverband Kliniken im Mühlenkreis	Minden
Germany	Medizinische Klinik - Innenstadt	München
Germany	Ruppiner Kliniken GmbH	Neuruppin
Germany	Johanniter-Krankenhaus im Fläming gGmbH	Treuenbrietzen
Germany	Universitätsklinikum Ulm	Ulm

Sponsors (1)

Lead Sponsor	Collaborator
LungenClinic Grosshansdorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the progression free survival rate with the first-line therapy		Tumour assessment every other cycle (interval of 42 days)	No
Secondary	Duration of remission		Tumour assessment every other cycle (interval of 42 days)	No
Secondary	1-year survival		1 year	No
Secondary	Overall survival		End of study	No
Secondary	Response rate (CR/RR)		Tumour assessment every other cycle (interval of 42 days)	No
Secondary	Quality of life, improvement of symptoms (FACT-L)		Every other cycle (interval of 42 days)	No
Secondary	Simplified Charlsons´Comorbidity Score		baseline	No
Secondary	Safety and Tolerability		continously	Yes