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:
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT00193401
First received: September 12, 2005
Last updated: July 27, 2010
Last verified: July 2010
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by SCRI Development Innovations, LLC:

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
Estimated Study Completion Date: November 2004
Primary Completion Date: June 2004 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00193401

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

No publications provided

ClinicalTrials.gov Identifier: NCT00193401     History of Changes
Other Study ID Numbers: SCRI LUN 65, 104864665
Study First Received: September 12, 2005
Last Updated: July 27, 2010
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 28, 2014