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

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ClinicalTrials.gov Identifier: NCT00193401
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : July 28, 2010
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Lung Cancer Drug: Topotecan Phase 2

Detailed Description:

Upon determination of eligibility, all patients will be receive:

  • Topotecan

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Weekly Topotecan in the First-line Treatment of Elderly Patients With Small Cell Lung Cancer
Study Start Date : August 2002
Primary Completion Date : June 2004
Estimated Study Completion Date : November 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Overall response rate

Secondary Outcome Measures :
  1. Median survival
  2. 1 year and 2 year survival
  3. Overall toxicity

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00193401

Sponsors and Collaborators
SCRI Development Innovations, LLC
Institutional Review Board TriStar Nashville Market
Principal Investigator: Anthony Greco, MD SCRI Development Innovations, LLC
More Information

ClinicalTrials.gov Identifier: NCT00193401     History of Changes
Other Study ID Numbers: SCRI LUN 65
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: July 28, 2010
Last Verified: July 2010

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents