Weekly Topotecan in the First-Line Treatment of Elderly Patients With Small Cell Lung Cancer

This study is ongoing, but not recruiting participants.

First Received: September 12, 2005 Last Updated: October 2, 2007 History of Changes

Sponsors and Collaborators:	Sarah Cannon Research Institute Institutional Review Board TriStar Nashville Market
Information provided by:	Sarah Cannon Research Institute
ClinicalTrials.gov Identifier:	NCT00193401

Purpose

In this phase II trial, we will evaluate the weekly schedule of topotecan in the first-line treatment of elderly and/or poor performance status patients with extensive stage small cell lung cancer. Patients eligible for this trial will be those considered poor candidates for standard combination chemotherapy or other investigational regimens

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 First-Line Treatment of Elderly Patients With 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 and 2 year survival
Overall toxicity

Estimated Enrollment:	40
Study Start Date:	August 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:

Biopsy-proven small cell lung cancer, extensive stage disease
Age > 65 years
No previous chemotherapy or radiation therapy.
Measurable or evaluable disease.
Adequate bone marrow, liver and kidney function.
Must be > 4 weeks from previous major surgery
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:

Meningeal involvement
Serious active infections
Serious underlying medical conditions
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: NCT00193401

Sponsors and Collaborators

Sarah Cannon Research Institute

Institutional Review Board TriStar Nashville Market

Investigators

Principal Investigator:

Anthony Greco, MD

Sarah Cannon Research Institute

More Information

No publications provided

Study ID Numbers:	SCRI LUN 65, 104864665
Study First Received:	September 12, 2005
Last Updated:	October 2, 2007
ClinicalTrials.gov Identifier:	NCT00193401 History of Changes
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:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Carcinoma, Neuroendocrine
Antineoplastic Agents
Neoplasms, Nerve Tissue
Enzyme Inhibitors
Pharmacologic Actions
Carcinoma
Neuroendocrine Tumors
Carcinoma, Small Cell

Neuroectodermal Tumors
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Lung Diseases
Neoplasms, Germ Cell and Embryonal
Topotecan
Adenocarcinoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009