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Completed

NCT Number: NCT00193401

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

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

Upon determination of eligibility, all patients will be receive:

  • Topotecan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Topotecan

Drug

Primary outcomes

  1. Overall response rate

Secondary outcomes

  1. Median survival

  2. 1 year and 2 year survival

  3. Overall toxicity

Sponsors and collaborators

Lead sponsor

SCRI Development Innovations, LLC

Other

Collaborators

  • Institutional Review Board TriStar Nashville Market

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2004
Study completion
2004
First posted
Sep 19, 2005
Registry last updated
Jul 28, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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