Last updated: 11/03/2018 07:44:17
Topotecan Plus Cisplatin Versus Etoposide Plus Cisplatin In 1st Line Extensive Disease Small Cell Lung Cancer
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
2007-28-02
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
GSK Investigational Site
Grosshansdorf, Schleswig-Holstein, Germany, 22927
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Borstel, Schleswig-Holstein, Germany, 23845
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55131
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Karlsruhe, Baden-Wuerttemberg, Germany, 76137
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Greifswald, Mecklenburg-Vorpommern, Germany, 17487
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Wiesbaden, Hessen, Germany, 65199
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Greifenstein, Hessen, Germany, 35753
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Hamburg, Hamburg, Germany, 20246
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Bayreuth, Bayern, Germany, 95445
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Koblenz, Rheinland-Pfalz, Germany, 56073
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Hamm, Nordrhein-Westfalen, Germany, 59071
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Erfurt, Thueringen, Germany, 99089
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Rosenheim, Bayern, Germany, 83022
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Hamburg, Hamburg, Germany, 21075
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Duisburg, Nordrhein-Westfalen, Germany, 47228
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Trier, Rheinland-Pfalz, Germany, 54290
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Leer, Niedersachsen, Germany, 26789
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Herne, Nordrhein-Westfalen, Germany, 44625
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Nuernberg, Bayern, Germany, 90340
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Leipzig, Sachsen, Germany, 04207
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Rostock, Mecklenburg-Vorpommern, Germany, 18059
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Bonn, Nordrhein-Westfalen, Germany, 53111
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Frankfurt, Hessen, Germany, 60431
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Velbert, Nordrhein-Westfalen, Germany, 42551
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Frankfurt, Hessen, Germany, 65929
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Loewenstein, Baden-Wuerttemberg, Germany, 74245
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Waren, Mecklenburg-Vorpommern, Germany, 17192
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Bielefeld, Nordrhein-Westfalen, Germany, 33604
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Flensburg, Schleswig-Holstein, Germany, 24939
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Halle/Saale, Sachsen-Anhalt, Germany, 06114
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Oberhausen, Nordrhein-Westfalen, Germany, 46145
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Bonn, Nordrhein-Westfalen, Germany, 53113
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Coesfeld, Nordrhein-Westfalen, Germany, 48653
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Koeln, Nordrhein-Westfalen, Germany, 50931
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Neubrandenburg, Mecklenburg-Vorpommern, Germany, 17036
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Mannheim, Baden-Wuerttemberg, Germany, 68167
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Regensburg, Bayern, Germany, 93049
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Chemnitz, Sachsen, Germany, 09113
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Stralsund, Mecklenburg-Vorpommern, Germany, 18437
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Freiburg, Baden-Wuerttemberg, Germany, 79106
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Duisburg, Nordrhein-Westfalen, Germany, 47166
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Ludwigshafen, Rheinland-Pfalz, Germany, 67063
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Koeln, Nordrhein-Westfalen, Germany, 50924
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Goettingen, Niedersachsen, Germany, 37075
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Frankfurt/Oder, Brandenburg, Germany, 15236
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Wuppertal, Nordrhein-Westfalen, Germany, 42283
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Offenbach, Hessen, Germany, 63069
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Bochum, Nordrhein-Westfalen, Germany, 44791
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Magdeburg, Sachsen-Anhalt, Germany, 39120
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Muenchen, Bayern, Germany, 80336
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Hamburg, Hamburg, Germany, 22043
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Stade, Niedersachsen, Germany, 21680
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Rostock, Mecklenburg-Vorpommern, Germany, 18057
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Hemer, Nordrhein-Westfalen, Germany, 58675
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Dorsten, Nordrhein-Westfalen, Germany, 46282
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Wangen, Baden-Wuerttemberg, Germany, 88239
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Bonn, Nordrhein-Westfalen, Germany, 53177
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Cottbus, Brandenburg, Germany, 03048
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Krefeld, Nordrhein-Westfalen, Germany, 47798
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Jena, Thueringen, Germany, 07747
Status
Terminated/Withdrawn
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
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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