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Non-Small Cell Lung CancerPhase 2TIENCT00678964

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

A Phase 2 study testing Erlotinib and Vinorelbine and Carboplatin in people with Non-Small Cell Lung Cancer, run by LungenClinic Grosshansdorf at 40 sites in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 70 years and older
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
Erlotinib and Vinorelbine and Carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
260 participants
Where
40 sitesGermany
Study dates
Jun 2006to Nov 2008
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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
Show all 12Show fewer
  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

40 sites in 1 country.

40 sites in 1 country

Germany40 sites, 40 recruiting

  • Gemeinschaftspraxis

    Augsburg, 86150

    Heinrich, Dr., +41 821 344650

    Heinrich, Dr.

    Recruiting

  • Zentralklinik Bad Berka GmbH

    Bad Berka, 99437

    Bonnet, Dr., +41 36458 51500

    Bonnet, Dr.

    Recruiting

  • Charité - Campus Benjamin Franklin

    Berlin, 12200

    Alexander Schmittel, Dr., +41 30 84453090

    Alexander Schmittel, Dr.

    Recruiting

  • Helios Klinikum Emil von Behring

    Berlin, 14165

    Monika Serke, Dr., +41 30 80022304

    Monika Serke, Dr.

    Recruiting

  • Evangelische Lungenklinik Berlin

    Berlin

    Sylke Kurz, Dr., +41 30 94802112

    Sylke Kurz, Dr.

    Recruiting

  • Evang. Krankenhaus Bielefeld

    Bielefeld, 33611

    Meinolf Karthaus, Prof. Dr., +41 521 77275504

    Meinolf Karthaus, Prof. dr.

    Recruiting

  • Johanniter-Krankenhaus Bonn

    Bonn, 53113

    Yon-Dschun Ko, Prof. Dr., +41 228 5432202

    Yon-Dschun Ko, Prof. Dr.

    Recruiting

  • Gemeinschaftspraxis

    Celle, 29221

    Raack, Dr., +41 5141 9929490

    Raack, Dr.

    Recruiting

  • Malteser Krankenhaus St. Hildegardis Köln

    Cologne, 50931

    Michael von Eiff, Prof. Dr., +41 221 4003231

    Michael von Eiff, Prof. Dr.

    Recruiting

  • Fachkrankenhaus Coswig

    Coswig, 01640

    Gerd Höffken, Prof. Dr., +41 3523 65-0

    Gerd Höffken, Prof. Dr.

    Recruiting

  • Fachklinik Diekholzen

    Diekholzen, 31199

    Wolfram Meister, Dr., +41 5121 201383

    Wolfram Meister, Dr.

    Recruiting

  • Klinikum Donaustauf

    Donaustauf, 93093

    Norbert Meidenbauer, Dr., +41 9403 800

    Norbert Meidenbauer, Dr.

    Recruiting

  • Katholisches Klinikum Duisburg

    Duisburg, 47166

    Michael Schroeder, Dr., +41 203 5462482

    Michael Schroeder, Dr.

    Recruiting

  • Marien Hospital Düsseldorf

    Düsseldorf, 40479

    Schütte, Prof. Dr., +41 211 44002501

    Schütte, Prof. Dr.

    Recruiting

  • Universitätsklinik Essen

    Essen, 45122

    Eberhardt, Dr., +41 201 723-2168

    Eberhardt, Dr.

    Recruiting

  • Klinikum Essen-Mitte

    Essen, 45136

    Koester, Prof. Dr., +41 201 1741251

    Koester, Prof. Dr.

    Recruiting

  • Krankenhaus Nordwest GmbH

    Frankfurt am Main, 60488

    Elke Jäger, Prof. Dr., +41 69 76013340

    Elke Jäger, Prof. Dr.

    Recruiting

  • Asklepios Fachkliniken München-Gauting

    Gauting, 82131

    von Pawel, Dr., +41 89 857912011

    von Pawel, Dr.

    Recruiting

  • Schwerpunktpraxis Onkologie

    Goslar, 38642

    Tessen, Dr., +41 5321 686102

    Tessen, Dr.

    Recruiting

  • Georg-August-Universität Göttingen

    Göttingen, 37075

    Schüttrumpf, Dr., +41 551 398538

    Schüttrumpf, Dr.

    Recruiting

  • Universitätsklinikum der Ernst-Moritz Arndt Universität Greifswald

    Greifswald, 17475

    Ralf Ewert, Prof. Dr., +41 3834 866776

    Ralf Ewert, Prof. Dr.

    Recruiting

  • Krankenhaus Großhansdorf

    Großhansdorf, 22927

    Martin Reck, Dr., +41 4102 601188

    Martin Reck, Dr.

    Recruiting

  • Allgemeines Krankenhaus Harburg

    Hamburg, 21075

    Kaukel, Prof. Dr., +41 40 1818860

    Kaukel, Prof. Dr.

    Recruiting

  • Medizinische Hochschule Hannover

    Hanover, 30625

    Nicolas Dickgreber, Dr., +41 511 5323934

    Nicolas Dickgreber, Dr.

    Recruiting

  • Thoraxklinik am Universitätsklinikum Heidelberg

    Heidelberg, 69126

    Michael Thomas, Prof. Dr., +41 6221 3961300

    Michael Thomas, Prof. Dr.

    Recruiting

  • Lungenklinik Hemer

    Hemer, 58675

    Lutz Freitag, Dr., +41 2372 9082201

    Lutz Freitag, Dr.

    Recruiting

  • Universitätsklinik des Saarlandes

    Homburg/Saar, 66421

    Andreas Göschel, Dr., +41 8641 1623614

    Andreas Göschel, Dr.

    Recruiting

  • Klinikum der Friedrich-Schiller-Universität

    Jena, 07740

    Angelika Reißig, Dr., +41 3641 9329131

    Angelika Reißig, Dr.

    Recruiting

  • Klinikum Kassel

    Kassel, 34125

    Martin Wolf, Prof. Dr., +41 561 9803045

    Martin Wolf, Prof. Dr.

    Recruiting

  • Klinikum Leverkusen gGmbH

    Leverkusen, 51375

    Niederle, Prof. Dr., +41 214 132672

    Niederle, Prof. Dr.

    Recruiting

  • Klinik Löwenstein gGmbH

    Löwenstein, 74245

    Fischer, Dr., +41 7130 15-0

    Fischer, Dr.

    Recruiting

  • Universitätsklinikum Schleswig-Holstein

    Lübeck, 23538

    Dalhoff, Prof. Dr., +41 451 5002375

    Dalhoff, Prof. Dr.

    Recruiting

  • Katholisches Klinikum Mainz

    Mainz, 55131

    Kortsik, Prof. Dr., +41 6131 147412

    Kortsik, Prof. Dr.

    Recruiting

  • Klinikum der Johannes Gutenberg-Universität Mainz

    Mainz, 55131

    Fischer, Dr., +41 6131 177135

    Fischer, Dr.

    Recruiting

  • Universitätsklinikum Mannheim gGmbH

    Mannheim, 68167

    Dieter Buchheidt, Dr., +41 621 3834110

    Dieter Buchheidt, Dr.

    Recruiting

  • Zweckverband Kliniken im Mühlenkreis

    Minden, 32423

    Bodenstein, Prof. Dr., +41 571 801-4810

    Bodenstein, Prof. Dr.

    Recruiting

  • Medizinische Klinik - Innenstadt

    München, 80336

    Huber, Prof. Dr., +41 89 51602590

    Huber, Prof. Dr.

    Recruiting

  • Ruppiner Kliniken GmbH

    Neuruppin, 16816

    Deppermann, Dr., +49 3391 393112

    Deppermann, Dr.

    Recruiting

  • Johanniter-Krankenhaus im Fläming gGmbH

    Treuenbrietzen, 14929

    Steffi Mai, Dr., +41 33748 82441

    Steffi Mai, Dr.

    Recruiting

  • Universitätsklinikum Ulm

    Ulm, 89081

    Stefan Schumann, Dr., +41 731 50024453

    Stefan Krüger, Dr.

    Recruiting

Other trials in Germany

About this study

Official title: 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.

Being tested
Erlotinib, Vinorelbine and Carboplatin
Keywords
NSCLC, Elderly patients
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ErlotinibDrug

    Also called Tarceva

    Erlotinib 150 mg, p.o., once daily

  • Vinorelbine and CarboplatinDrug

    Also called Navelbine, Carboplat

    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

Study groups in NCT00678964
Study groupRoleWhat they receive
AExperimentalNot described
Receives: Drug: Erlotinib
BActive comparatorNot described
Receives: Drug: Vinorelbine and Carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluation of the progression free survival rate with the first-line therapy

    Measured: Tumour assessment every other cycle (interval of 42 days)

Secondary outcomes (7)

  1. Duration of remission

    Measured: Tumour assessment every other cycle (interval of 42 days)

  2. 1-year survival

    Measured: 1 year

  3. Overall survival

    Measured: End of study

  4. Response rate (CR/RR)

    Measured: Tumour assessment every other cycle (interval of 42 days)

  5. Quality of life, improvement of symptoms (FACT-L)

    Measured: Every other cycle (interval of 42 days)

  6. Simplified Charlsons´Comorbidity Score

    Measured: baseline

  7. Safety and Tolerability

    Measured: continously

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2008 (estimated)
  2. Study startJun 2006
  3. Primary completionNov 2008 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
260 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00678964
Sponsor's protocol ID
EudraCT 2005-005827-32
Other IDs
ML19747
Acronym
TIE
Status last verified
May 2008
First submitted
14 May 2008
Last updated
16 May 2008
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Erlotinib and Vinorelbine and Carboplatin in people with Non-Small Cell Lung Cancer, run by LungenClinic Grosshansdorf at 40 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 May 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of the progression free survival rate with the first-line therapy (time frame: Tumour assessment every other cycle (interval of 42 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00678964.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2008.

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