Clinical trial NCT00320359: Topotecan Plus Cisplatin Versus Etoposide Plus Cisplatin In 1st Line Extensive Disease Small Cell Lung Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lung Cancer, Small Cell
Keywords: First-line Cisplatin
Small Cell Lung Cancer
topotecan
etoposide
Extensive Disease
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-05-03
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluation of intravenous Topotecan + Cisplatin as a potential new standard of care in 1st line Small Cell Lung Cancer


Eligibility 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.

Primary outcomes:
measure: Median overall survival time of participants
timeFrame: Up to 1 year after randomization of the last patient
Secondary outcomes:
measure: Number of participants with one year survival rate of the participants
timeFrame: Up to 1 year after randomization of the last patient
measure: Median time of disease progression
timeFrame: up to 1 year after randomization of the last patient
measure: Median time to event (progressive disease or death) of participants
timeFrame: Up to 1 year after randomization of the last patient
measure: Median time to response to chemotherapy
timeFrame: Up to 1 year after randomization of the last patient
measure: Median response duration
timeFrame: Up to 1 year after randomization of the last patient
measure: Number of participants with objective response
timeFrame: Up to 1 year after randomization of the last patient
measure: Mean lung cancer symptom score (LCSS)
timeFrame: Up to 18 weeks
measure: Mean eastern cooperative oncology group (ECOG) score
timeFrame: Up to 18 weeks
measure: Number of participants with adverse events (AEs) and serious adverse events (SAEs)
timeFrame: Up to 1 year after randomization of the last patient
measure: Mean change from Baseline in hemoglobin value
timeFrame: Baseline and up to 18 weeks
measure: Mean change from Baseline in leukocytes, neutrophils and platelets count
timeFrame: Baseline and up to 18 weeks
measure: Mean change from Baseline in red blood cells (RBCs)
timeFrame: Baseline and up to 18 weeks
measure: Mean change from Baseline in Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Alkaline phosphatase and Lactate dehydrogenase (LDH)
timeFrame: Baseline and up to 18 weeks
measure: Mean change from Baseline in Blood urea nitrogen (BUN), Potassium, Sodium and urea
timeFrame: Baseline and up to 18 weeks
measure: Mean change from Baseline in Creatinine and Total bilirubin
timeFrame: Baseline and up to 18 weeks
measure: Mean change from Baseline in Creatinine clearance
measure: Mean change from Baseline in total protein
timeFrame: Baseline and up to 18 weeks
measure: Number of participants with abnormal urinalysis results
measure: Mean change from Baseline in weight
timeFrame: Baseline and up to 18 weeks
measure: Mean change from Baseline in Body surface area
timeFrame: Baseline and up to 18 weeks
Other outcomes:
Locations:
city: Bludesch
country: Austria
facility: GSK Investigational Site
city: Klagenfurt
country: Austria
facility: GSK Investigational Site
city: Linz
country: Austria
facility: GSK Investigational Site
city: Vienna
country: Austria
facility: GSK Investigational Site
city: Freiburg
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Karlsruhe
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Loewenstein
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Mannheim
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Wangen
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Bayreuth
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Nuernberg
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Passau
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Regensburg
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Rosenheim
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Cottbus
country: Germany
facility: GSK Investigational Site
state: Brandenburg
city: Frankfurt/Oder
country: Germany
facility: GSK Investigational Site
state: Brandenburg
city: Frankfurt
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Frankfurt
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Giessen
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Greifenstein
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Kassel
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Limburg
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Marburg
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Offenbach
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Wiesbaden
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Greifswald
country: Germany
facility: GSK Investigational Site
state: Mecklenburg-Vorpommern
city: Neubrandenburg
country: Germany
facility: GSK Investigational Site
state: Mecklenburg-Vorpommern
city: Rostock
country: Germany
facility: GSK Investigational Site
state: Mecklenburg-Vorpommern
city: Rostock
country: Germany
facility: GSK Investigational Site
state: Mecklenburg-Vorpommern
city: Stralsund
country: Germany
facility: GSK Investigational Site
state: Mecklenburg-Vorpommern
city: Waren
country: Germany
facility: GSK Investigational Site
state: Mecklenburg-Vorpommern
city: Goettingen
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Leer
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Stade
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Bielefeld
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Bochum
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Bonn
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Bonn
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Bonn
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Coesfeld
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Dorsten
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Duisburg
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Duisburg
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Hamm
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Hemer
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Herne
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Koeln
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Koeln
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Krefeld
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Oberhausen
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Velbert
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Wuppertal
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Koblenz
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Ludwigshafen
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Mainz
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Trier
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Halle/Saale
country: Germany
facility: GSK Investigational Site
state: Sachsen-Anhalt
city: Magdeburg
country: Germany
facility: GSK Investigational Site
state: Sachsen-Anhalt
city: Chemnitz
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Leipzig
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Plauen
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Borstel
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Flensburg
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Grosshansdorf
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Erfurt
country: Germany
facility: GSK Investigational Site
state: Thueringen
city: Jena
country: Germany
facility: GSK Investigational Site
state: Thueringen
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Bremen
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: