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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2008 by LungenClinic Grosshansdorf.
Recruitment status was:  Recruiting
Sponsor:
Information provided by:
LungenClinic 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 LungenClinic 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   (Senior)
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
Augsburg, Germany, 86150
Zentralklinik Bad Berka GmbH
Bad Berka, Germany, 99437
Charité - Campus Benjamin Franklin
Berlin, Germany, 12200
Helios Klinikum Emil von Behring
Berlin, Germany, 14165
Evangelische Lungenklinik Berlin
Berlin, Germany
Evang. Krankenhaus Bielefeld
Bielefeld, Germany, 33611
Johanniter-Krankenhaus Bonn
Bonn, Germany, 53113
Gemeinschaftspraxis
Celle, Germany, 29221
Fachkrankenhaus Coswig
Coswig, Germany, 01640
Fachklinik Diekholzen
Diekholzen, Germany, 31199
Klinikum Donaustauf
Donaustauf, Germany, 93093
Katholisches Klinikum Duisburg
Duisburg, Germany, 47166
Marien Hospital Düsseldorf
Düsseldorf, Germany, 40479
Universitätsklinik Essen
Essen, Germany, 45122
Klinikum Essen-Mitte
Essen, Germany, 45136
Krankenhaus Nordwest GmbH
Frankfurt/Main, Germany, 60488
Asklepios Fachkliniken München-Gauting
Gauting, Germany, 82131
Schwerpunktpraxis Onkologie
Goslar, Germany, 38642
Universitätsklinikum der Ernst-Moritz Arndt Universität Greifswald
Greifswald, Germany, 17475
Krankenhaus Großhansdorf
Großhansdorf, Germany, 22927
Georg-August-Universität Göttingen
Göttingen, Germany, 37075
Allgemeines Krankenhaus Harburg
Hamburg, Germany, 21075
Medizinische Hochschule Hannover
Hannover, Germany, 30625
Thoraxklinik am Universitätsklinikum Heidelberg
Heidelberg, Germany, 69126
Lungenklinik Hemer
Hemer, Germany, 58675
Universitätsklinik des Saarlandes
Homburg/Saar, Germany, 66421
Klinikum der Friedrich-Schiller-Universität
Jena, Germany, 07740
Klinikum Kassel
Kassel, Germany, 34125
Malteser Krankenhaus St. Hildegardis Köln
Köln, Germany, 50931
Klinikum Leverkusen gGmbH
Leverkusen, Germany, 51375
Klinik Löwenstein gGmbH
Loewenstein, Germany, 74245
Universitätsklinikum Schleswig-Holstein
Lübeck, Germany, 23538
Katholisches Klinikum Mainz
Mainz, Germany, 55131
Klinikum der Johannes Gutenberg-Universität Mainz
Mainz, Germany, 55131
Universitätsklinikum Mannheim gGmbH
Mannheim, Germany, 68167
Zweckverband Kliniken im Mühlenkreis
Minden, Germany, 32423
Medizinische Klinik - Innenstadt
München, Germany, 80336
Ruppiner Kliniken GmbH
Neuruppin, Germany, 16816
Johanniter-Krankenhaus im Fläming gGmbH
Treuenbrietzen, Germany, 14929
Universitätsklinikum Ulm
Ulm, Germany, 89081
Sponsors and Collaborators
LungenClinic Grosshansdorf
Investigators
Principal Investigator: Martin Reck, Dr. LungenClinic Grosshansdorf
  More Information

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 LungenClinic Grosshansdorf:
NSCLC
Elderly patients

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

ClinicalTrials.gov processed this record on December 02, 2016