Weekly Topotecan in the Second-Line Treatment of Small Cell Lung Cancer

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators:	Sarah Cannon Research Institute GlaxoSmithKline
Information provided by:	Sarah Cannon Research Institute
ClinicalTrials.gov Identifier:	NCT00193388

Purpose

In this phase II trial, we will evaluate the weekly schedule of topotecan in the second-line treatment of patients with small cell lung cancer

Condition	Intervention	Phase
Lung Cancer	Drug: Topotecan	Phase II

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Topotecan hydrochloride Topotecan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase II Trial of Weekly Topotecan in the Second-Line Treatment of Small Cell Lung Cancer

Further study details as provided by Sarah Cannon Research Institute:

Primary Outcome Measures:

Overall response rate

Secondary Outcome Measures:

Median survival
1-year survival
Symptomatic improvement

Estimated Enrollment:	100
Study Start Date:	September 2002

Detailed Description:

Upon determination of eligibility, all patients will be receive:

Topotecan

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

To be included in this study, you must meet the following criteria:

Small Cell Lung cancer
Progression after one previous regimen
Measurable or evaluable disease
Able to perform activities of daily living with assistance
Adequate bone marrow, liver and kidney function
No more than three previous courses of radiation therapy
Accessible for treatment and follow up
Must give written informed consent prior to study entry

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

Central nervous system involvement
Serious or active infection
Serious underlying medical condition
Other active neoplasms

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00193388

Sponsors and Collaborators

Sarah Cannon Research Institute

GlaxoSmithKline

Investigators

Principal Investigator:

Anthony Greco, MD

Sarah Cannon Research Institute

More Information

Study ID Numbers:	SCRI LUN 66, 104864664
Study First Received:	September 12, 2005
Last Updated:	October 2, 2007
ClinicalTrials.gov Identifier:	NCT00193388
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Thoracic Neoplasms
Carcinoma, Neuroendocrine
Carcinoma
Neuroendocrine Tumors
Carcinoma, Small Cell
Neuroectodermal Tumors
Respiratory Tract Diseases

Lung Neoplasms
Lung Diseases
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Topotecan
Adenocarcinoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents
Therapeutic Uses
Neoplasms, Nerve Tissue
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009