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

Lung Cancer, Small Cell Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00320359
• Other study ID #: 104864-A/479
• Status: Completed
• Phase: Phase 3
• First received: May 1, 2006
• Last updated: February 27, 2017
• Start date: August 2002
• Est. completion date: February 2007

Study information

• Verified date: February 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 700
• Est. completion date: February 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer, Small Cell
• Lung Neoplasms
• Small Cell Lung Carcinoma

Intervention

Drug:
• Intravenous topotecan/cisplatin
Topotecan 1 mg/m2 should be administered intravenously over a period of 30 minutes on days 1-5. Then a 30 minute saline flush should be administered followed by the cisplatin on day 5. Cisplatin 75 mg/m2 given as an intravenous infusion at the rate of 1 mg/min on day 5 after topotecan.
• Intravenous etoposide/cisplatin
Cisplatin 75 mg/m2 given as an intravenous infusion at the rate of 1 mg/min on day 1. Cisplatin should be given simultaneously to post-hydration to ensure a high volume fluid. Etoposide 100 mg/m2 should be administered after cisplatin intravenously over a period not less than 30 minutes on days 1 -3.

Locations

Country	Name	City	State
Austria	GSK Investigational Site	Bludesch
Austria	GSK Investigational Site	Klagenfurt
Austria	GSK Investigational Site	Linz
Austria	GSK Investigational Site	Vienna
Germany	GSK Investigational Site	Bayreuth	Bayern
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Bielefeld	Nordrhein-Westfalen
Germany	GSK Investigational Site	Bochum	Nordrhein-Westfalen
Germany	GSK Investigational Site	Bonn	Nordrhein-Westfalen
Germany	GSK Investigational Site	Bonn	Nordrhein-Westfalen
Germany	GSK Investigational Site	Bonn	Nordrhein-Westfalen
Germany	GSK Investigational Site	Borstel	Schleswig-Holstein
Germany	GSK Investigational Site	Bremen
Germany	GSK Investigational Site	Chemnitz	Sachsen
Germany	GSK Investigational Site	Coesfeld	Nordrhein-Westfalen
Germany	GSK Investigational Site	Cottbus	Brandenburg
Germany	GSK Investigational Site	Dorsten	Nordrhein-Westfalen
Germany	GSK Investigational Site	Duisburg	Nordrhein-Westfalen
Germany	GSK Investigational Site	Duisburg	Nordrhein-Westfalen
Germany	GSK Investigational Site	Erfurt	Thueringen
Germany	GSK Investigational Site	Flensburg	Schleswig-Holstein
Germany	GSK Investigational Site	Frankfurt	Hessen
Germany	GSK Investigational Site	Frankfurt	Hessen
Germany	GSK Investigational Site	Frankfurt/Oder	Brandenburg
Germany	GSK Investigational Site	Freiburg	Baden-Wuerttemberg
Germany	GSK Investigational Site	Giessen	Hessen
Germany	GSK Investigational Site	Goettingen	Niedersachsen
Germany	GSK Investigational Site	Greifenstein	Hessen
Germany	GSK Investigational Site	Greifswald	Mecklenburg-Vorpommern
Germany	GSK Investigational Site	Grosshansdorf	Schleswig-Holstein
Germany	GSK Investigational Site	Halle/Saale	Sachsen-Anhalt
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hamm	Nordrhein-Westfalen
Germany	GSK Investigational Site	Hemer	Nordrhein-Westfalen
Germany	GSK Investigational Site	Herne	Nordrhein-Westfalen
Germany	GSK Investigational Site	Jena	Thueringen
Germany	GSK Investigational Site	Karlsruhe	Baden-Wuerttemberg
Germany	GSK Investigational Site	Kassel	Hessen
Germany	GSK Investigational Site	Koblenz	Rheinland-Pfalz
Germany	GSK Investigational Site	Koeln	Nordrhein-Westfalen
Germany	GSK Investigational Site	Koeln	Nordrhein-Westfalen
Germany	GSK Investigational Site	Krefeld	Nordrhein-Westfalen
Germany	GSK Investigational Site	Leer	Niedersachsen
Germany	GSK Investigational Site	Leipzig	Sachsen
Germany	GSK Investigational Site	Limburg	Hessen
Germany	GSK Investigational Site	Loewenstein	Baden-Wuerttemberg
Germany	GSK Investigational Site	Ludwigshafen	Rheinland-Pfalz
Germany	GSK Investigational Site	Magdeburg	Sachsen-Anhalt
Germany	GSK Investigational Site	Mainz	Rheinland-Pfalz
Germany	GSK Investigational Site	Mannheim	Baden-Wuerttemberg
Germany	GSK Investigational Site	Marburg	Hessen
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Neubrandenburg	Mecklenburg-Vorpommern
Germany	GSK Investigational Site	Nuernberg	Bayern
Germany	GSK Investigational Site	Oberhausen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Offenbach	Hessen
Germany	GSK Investigational Site	Passau	Bayern
Germany	GSK Investigational Site	Plauen	Sachsen
Germany	GSK Investigational Site	Regensburg	Bayern
Germany	GSK Investigational Site	Rosenheim	Bayern
Germany	GSK Investigational Site	Rostock	Mecklenburg-Vorpommern
Germany	GSK Investigational Site	Rostock	Mecklenburg-Vorpommern
Germany	GSK Investigational Site	Stade	Niedersachsen
Germany	GSK Investigational Site	Stralsund	Mecklenburg-Vorpommern
Germany	GSK Investigational Site	Trier	Rheinland-Pfalz
Germany	GSK Investigational Site	Velbert	Nordrhein-Westfalen
Germany	GSK Investigational Site	Wangen	Baden-Wuerttemberg
Germany	GSK Investigational Site	Waren	Mecklenburg-Vorpommern
Germany	GSK Investigational Site	Wiesbaden	Hessen
Germany	GSK Investigational Site	Wuppertal	Nordrhein-Westfalen

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Austria,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median overall survival time of participants		Up to 1 year after randomization of the last patient
Secondary	Number of participants with one year survival rate of the participants		Up to 1 year after randomization of the last patient
Secondary	Median time of disease progression		up to 1 year after randomization of the last patient
Secondary	Median time to event (progressive disease or death) of participants		Up to 1 year after randomization of the last patient
Secondary	Median time to response to chemotherapy		Up to 1 year after randomization of the last patient
Secondary	Median response duration		Up to 1 year after randomization of the last patient
Secondary	Number of participants with objective response		Up to 1 year after randomization of the last patient
Secondary	Mean lung cancer symptom score (LCSS)		Up to 18 weeks
Secondary	Mean eastern cooperative oncology group (ECOG) score		Up to 18 weeks
Secondary	Number of participants with adverse events (AEs) and serious adverse events (SAEs)		Up to 1 year after randomization of the last patient
Secondary	Mean change from Baseline in hemoglobin value		Baseline and up to 18 weeks
Secondary	Mean change from Baseline in leukocytes, neutrophils and platelets count		Baseline and up to 18 weeks
Secondary	Mean change from Baseline in red blood cells (RBCs)		Baseline and up to 18 weeks
Secondary	Mean change from Baseline in Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Alkaline phosphatase and Lactate dehydrogenase (LDH)		Baseline and up to 18 weeks
Secondary	Mean change from Baseline in Blood urea nitrogen (BUN), Potassium, Sodium and urea		Baseline and up to 18 weeks
Secondary	Mean change from Baseline in Creatinine and Total bilirubin		Baseline and up to 18 weeks
Secondary	Mean change from Baseline in Creatinine clearance
Secondary	Mean change from Baseline in total protein		Baseline and up to 18 weeks
Secondary	Number of participants with abnormal urinalysis results
Secondary	Mean change from Baseline in weight		Baseline and up to 18 weeks
Secondary	Mean change from Baseline in Body surface area		Baseline and up to 18 weeks