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

This study has been completed.

First Received: May 1, 2006 Last Updated: July 17, 2007 History of Changes

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00320359

Purpose

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

Condition	Intervention	Phase
Small Cell Lung Cancer	Drug: Intravenous topotecan/cisplatin Drug: Intravenous etoposide/cisplatin	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Cisplatin Etoposide Etoposide phosphate Topotecan hydrochloride Topotecan

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Overall survival

Secondary Outcome Measures:

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 ]

Enrollment:	700
Study Start Date:	May 2002

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00320359

Show 81 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trial, MD

GlaxoSmithKline

More Information

No publications provided

Study ID Numbers:	104864-A/479
Study First Received:	May 1, 2006
Last Updated:	July 17, 2007
ClinicalTrials.gov Identifier:	NCT00320359 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by GlaxoSmithKline:

Small Cell Lung Cancer
Extensive Disease
First-line Cisplatin
topotecan
etoposide

Study placed in the following topic categories:

Thoracic Neoplasms
Carcinoma, Neuroendocrine
Etoposide phosphate
Carcinoma
Neuroendocrine Tumors
Carcinoma, Small Cell
Neuroectodermal Tumors
Radiation-Sensitizing Agents
Cisplatin
Respiratory Tract Diseases

Lung Neoplasms
Lung Diseases
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Topotecan
Adenocarcinoma
Antineoplastic Agents, Phytogenic
Etoposide
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Thoracic Neoplasms
Molecular Mechanisms of Pharmacological Action
Carcinoma, Neuroendocrine
Antineoplastic Agents
Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Etoposide phosphate
Neoplasms by Site
Respiratory Tract Diseases
Cisplatin
Lung Neoplasms
Neoplasms, Germ Cell and Embryonal
Therapeutic Uses
Etoposide
Respiratory Tract Neoplasms

Neoplasms by Histologic Type
Enzyme Inhibitors
Pharmacologic Actions
Neuroendocrine Tumors
Carcinoma
Carcinoma, Small Cell
Neuroectodermal Tumors
Neoplasms
Radiation-Sensitizing Agents
Lung Diseases
Adenocarcinoma
Topotecan
Antineoplastic Agents, Phytogenic
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on July 02, 2009