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

Tracking Information

First Received Date ^ICMJE

May 1, 2006

Last Updated Date

August 13, 2009

Start Date ^ICMJE

August 2002

Primary Completion Date

February 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Overall survival [ Time Frame: Duration of study ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Overall survival

Change History

Complete list of historical versions of study NCT00320359 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

1 year survival rate, objective response rate, response duration, time to response, time to progression, tolerability, patient-perceived disease status, and well being in each treatment arm [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

1 year survival rate, objective response rate, response duration, time to response, time to progression, tolerability, patient-perceived disease status, and well being in each treatment arm

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Small Cell Lung Cancer

Intervention ^ICMJE

Drug: Intravenous etoposide/cisplatin
Drug: Intravenous topotecan/cisplatin

Study Arms / Comparison Groups

Active Comparator: Cisplatin 75 mg/m2 i.v., day 1, Etoposide 100 mg/m2 i.v., days 1-3
Experimental: Topotecan 1 mg/ m2, i.v., days 1-5 Cisplatin 75 mg/m2 i.v., days 5

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

700

Completion Date

February 2007

Primary Completion Date

February 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Austria, Germany

Administrative Information

NCT ID ^ICMJE

NCT00320359

Responsible Party

Study Director, GSK

Study ID Numbers ^ICMJE

104864-A/479

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

GSK Clinical Trials

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

August 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP