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Topotecan Plus Cisplatin Versus Etoposide Plus Cisplatin In 1st Line Extensive Disease Small Cell Lung Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

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

NCT00320359•GlaxoSmithKline

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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.

Locations (79)

GSK Investigational Site

Bludesch, Austria

GSK Investigational Site

Klagenfurt, Austria

GSK Investigational Site

Linz, Austria

GSK Investigational Site

Vienna, Austria

GSK Investigational Site

Freiburg im Breisgau, Baden-Wurttemberg, Germany

GSK Investigational Site

Karlsruhe, Baden-Wurttemberg, Germany

GSK Investigational Site

Löwenstein, Baden-Wurttemberg, Germany

GSK Investigational Site

Mannheim, Baden-Wurttemberg, Germany

GSK Investigational Site

Wangen, Baden-Wurttemberg, Germany

GSK Investigational Site

Bayreuth, Bavaria, Germany

Key Dates

Start Date

August 1, 2002

Primary Completion Date

February 1, 2007

Completion Date

February 1, 2007

Last Updated

March 1, 2017

Enrollment

700

ACTUAL participants

Conditions

Lung Cancer, Small Cell

Interventions

Intravenous topotecan/cisplatin

DRUG

Intravenous etoposide/cisplatin

DRUG

Engagement of Veterans With Lung Cancer

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UNKNOWNPHASE2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 1, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Engagement of Veterans With Lung Cancer

A Study to Investigate the Efficacy and Safety of Tislelizumab Combined With Sitravatinib as Maintenance Therapy for ES-SCLC

Trial Of Cisplatin And KML-001 in Platinum Responsive Malignancies