Last updated: 11/03/2018 07:44:17

Topotecan Plus Cisplatin Versus Etoposide Plus Cisplatin In 1st Line Extensive Disease Small Cell Lung Cancer

GSK study ID
104864-A/479
See study documents
Clinicaltrials.gov ID
NCT00320359
See results summary
EudraCT ID
2005-000675-18
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: An Open-Label, Multicentre, Randomised, Phase III Study Comparing Topotecan/Cisplatin and Topotecan/Etoposide versus Etoposide/Cisplatin as Treatment for Chemotherapy-naive Patients with Extensive Disease-Small Cell Lung Cancer
Trial description: Evaluation of intravenous Topotecan + Cisplatin as a potential new standard of care in 1st line Small Cell Lung Cancer
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Median overall survival time of participants

Timeframe: Up to 1 year after randomization of the last participant

Secondary outcomes:

Percentage of participants with one year survival rate

Timeframe: Up to 1 year after randomization of the last participant

Median time of disease progression

Timeframe: Up to 1 year after randomization of the last participant

Median time to event (progressive disease or death) of participants

Timeframe: Up to 1 year after randomization of the last participant

Median time to response to chemotherapy

Timeframe: Up to 1 year after randomization of the last participant

Median response duration

Timeframe: Up to 1 year after randomization of the last participant

Percentage of participants with objective response

Timeframe: Up to 1 year after randomization of the last participant

Area under curve (AUC) of lung cancer symptom scale (LCSS) score over the course of treatment

Timeframe: Up to 18 weeks

Mean eastern cooperative oncology group (ECOG) score

Timeframe: Up to 18 weeks

Number of participants with adverse events (AEs) and serious adverse events (SAEs)

Timeframe: Up to 1 year after randomization of the last participant (approximately 4.5 years).

Interventions:
  • Drug: Intravenous topotecan/cisplatin
  • Drug: Intravenous etoposide/cisplatin
    • Enrollment:
    700
    Primary completion date:
    2007-28-02
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Lung Cancer, Small Cell
    Product
    topotecan
    Collaborators
    Not applicable
    Study date(s)
    August 2002 to February 2007
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 75 years
    Accepts healthy volunteers
    No
    • Evaluable extensive small cell lung cancer, extensive disease.
    • Eastern Cooperative Oncology Group (ECOG) performance status < 2.
    • Extensive disease treatable with radiotherapy.
    • Past or current history of other malignant disease.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Evaluable extensive small cell lung cancer, extensive disease.
    • Eastern Cooperative Oncology Group (ECOG) performance status < 2.
    • Life expectancy > 3 months.
    • Fit to receive any of the treatments.
    • No prior chemotherapy.
    • Written informed consent.
    Exclusion criteria:
    • Extensive disease treatable with radiotherapy.
    • Past or current history of other malignant disease.
    • Prior chemotherapy.
    • Pregnancy, lactating or lack of effective contraception.
    • Concurrent severe medical problems other than small cell lung cancer.
    • Patients with central nervous system metastases receiving more than 12 mg /day dexamethasone or equivalent to control symptoms.

    Trial location(s)

    Location
    Status
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    Location
    GSK Investigational Site
    Grosshansdorf, Schleswig-Holstein, Germany, 22927
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Borstel, Schleswig-Holstein, Germany, 23845
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Mainz, Rheinland-Pfalz, Germany, 55131
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Karlsruhe, Baden-Wuerttemberg, Germany, 76137
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Greifswald, Mecklenburg-Vorpommern, Germany, 17487
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Plauen, Sachsen, Germany, 08529
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Wiesbaden, Hessen, Germany, 65199
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Greifenstein, Hessen, Germany, 35753
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Hamburg, Hamburg, Germany, 20246
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Bayreuth, Bayern, Germany, 95445
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Koblenz, Rheinland-Pfalz, Germany, 56073
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Hamm, Nordrhein-Westfalen, Germany, 59071
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Erfurt, Thueringen, Germany, 99089
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Berlin, Berlin, Germany, 13125
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Rosenheim, Bayern, Germany, 83022
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Hamburg, Hamburg, Germany, 21075
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Duisburg, Nordrhein-Westfalen, Germany, 47228
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Trier, Rheinland-Pfalz, Germany, 54290
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Marburg, Hessen, Germany, 35043
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Leer, Niedersachsen, Germany, 26789
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Herne, Nordrhein-Westfalen, Germany, 44625
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Nuernberg, Bayern, Germany, 90340
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Kassel, Hessen, Germany, 34125
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Leipzig, Sachsen, Germany, 04207
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Rostock, Mecklenburg-Vorpommern, Germany, 18059
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Berlin, Berlin, Germany, 14109
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Bonn, Nordrhein-Westfalen, Germany, 53111
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Frankfurt, Hessen, Germany, 60431
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Linz, Austria, A-4020
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Velbert, Nordrhein-Westfalen, Germany, 42551
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Frankfurt, Hessen, Germany, 65929
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Loewenstein, Baden-Wuerttemberg, Germany, 74245
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Bremen, Bremen, Germany, 28325
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Waren, Mecklenburg-Vorpommern, Germany, 17192
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Bielefeld, Nordrhein-Westfalen, Germany, 33604
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Flensburg, Schleswig-Holstein, Germany, 24939
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Halle/Saale, Sachsen-Anhalt, Germany, 06114
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Berlin, Berlin, Germany, 12200
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Bludesch, Austria, A-6719
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Limburg, Hessen, Germany, 65549
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Oberhausen, Nordrhein-Westfalen, Germany, 46145
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Bonn, Nordrhein-Westfalen, Germany, 53113
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Coesfeld, Nordrhein-Westfalen, Germany, 48653
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Koeln, Nordrhein-Westfalen, Germany, 50931
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Vienna, Austria, A-1140
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Neubrandenburg, Mecklenburg-Vorpommern, Germany, 17036
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Mannheim, Baden-Wuerttemberg, Germany, 68167
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Passau, Bayern, Germany, 94032
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Regensburg, Bayern, Germany, 93049
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Chemnitz, Sachsen, Germany, 09113
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Stralsund, Mecklenburg-Vorpommern, Germany, 18437
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Berlin, Berlin, Germany, 13585
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Freiburg, Baden-Wuerttemberg, Germany, 79106
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Duisburg, Nordrhein-Westfalen, Germany, 47166
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Ludwigshafen, Rheinland-Pfalz, Germany, 67063
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Klagenfurt, Austria, A-9020
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Koeln, Nordrhein-Westfalen, Germany, 50924
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Giessen, Hessen, Germany, 35392
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Berlin, Berlin, Germany, 14089
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Goettingen, Niedersachsen, Germany, 37075
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Frankfurt/Oder, Brandenburg, Germany, 15236
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Wuppertal, Nordrhein-Westfalen, Germany, 42283
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Offenbach, Hessen, Germany, 63069
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Berlin, Berlin, Germany, 13353
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Bochum, Nordrhein-Westfalen, Germany, 44791
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Magdeburg, Sachsen-Anhalt, Germany, 39120
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Muenchen, Bayern, Germany, 80336
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Hamburg, Hamburg, Germany, 22043
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Stade, Niedersachsen, Germany, 21680
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Rostock, Mecklenburg-Vorpommern, Germany, 18057
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Hemer, Nordrhein-Westfalen, Germany, 58675
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Dorsten, Nordrhein-Westfalen, Germany, 46282
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Wangen, Baden-Wuerttemberg, Germany, 88239
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Berlin, Berlin, Germany, 12559
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Berlin, Berlin, Germany, 10117
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Bonn, Nordrhein-Westfalen, Germany, 53177
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Cottbus, Brandenburg, Germany, 03048
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Krefeld, Nordrhein-Westfalen, Germany, 47798
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Jena, Thueringen, Germany, 07747
    Status
    Terminated/Withdrawn
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    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2007-28-02
    Actual study completion date
    2007-28-02

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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