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

This study has been completed.
Sponsor:
Collaborator:
Institutional Review Board TriStar Nashville Market
Information provided by:
Sarah Cannon Research Institute
ClinicalTrials.gov Identifier:
NCT00193401
First received: September 12, 2005
Last updated: July 27, 2010
Last verified: July 2010
History of Changes

September 12, 2005
July 27, 2010
August 2002
June 2004   (final data collection date for primary outcome measure)
Overall response rate
Same as current
Complete list of historical versions of study NCT00193401 on ClinicalTrials.gov Archive Site
  • Median survival
  • 1 year and 2 year survival
  • Overall toxicity
Same as current
Not Provided
Not Provided
 
Weekly Topotecan in the First-line Treatment of Elderly Patients With Small Cell Lung Cancer
Phase II Trial of Weekly Topotecan in the First-line Treatment of Elderly Patients With Small Cell Lung Cancer

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

Upon determination of eligibility, all patients will be receive:

  • Topotecan
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lung Cancer
Drug: Topotecan
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
November 2004
June 2004   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00193401
SCRI LUN 65, 104864665
Not Provided
Not Provided
Sarah Cannon Research Institute
Institutional Review Board TriStar Nashville Market
Principal Investigator: Anthony Greco, MD Sarah Cannon Research Institute
Sarah Cannon Research Institute
July 2010

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