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

Sponsor:	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 etoposide/cisplatin Drug: Intravenous topotecan/cisplatin	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, 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 [ Time Frame: Duration of study ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

Enrollment:	700
Study Start Date:	August 2002
Study Completion Date:	February 2007
Primary Completion Date:	February 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm A: Active Comparator Cisplatin 75 mg/m2 i.v., day 1, Etoposide 100 mg/m2 i.v., days 1-3	Drug: 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.
Arm B: Experimental Topotecan 1 mg/ m2, i.v., days 1-5 Cisplatin 75 mg/m2 i.v., days 5	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.

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 79 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	104864-A/479
Study First Received:	May 1, 2006
Last Updated:	August 13, 2009
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

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 November 27, 2009