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Oral Topotecan Versus Docetaxel in Second-Line Treatment of Non-Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00193245
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : June 28, 2010
Aventis Pharmaceuticals
Information provided by:
SCRI Development Innovations, LLC

Brief Summary:
In this trial we will evaluate and compare the efficacy and toxicity of oral topotecan with intravenous docetaxel in the second-line treatment of patients with non-small cell lung cancer.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: Topotecan Drug: Docetaxel Phase 2

Detailed Description:

Upon determination of eligibility, patients will be randomly assigned to one of two treatment arms:

  • Topotecan
  • Docetaxel

For ever 2 patients treated, 1 will receive treatment A (Topotecan) and 1 will receive treatment B (Docetaxel). The study is not blinded so both the patient and the doctor will know which treatment has been assigned.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Trial of Oral Topotecan Versus Docetaxel in Second-Line Treatment of Non-Small Cell Lung Cancer
Study Start Date : November 2000
Actual Primary Completion Date : October 2005
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Primary Outcome Measures :
  1. Overall response rate

Secondary Outcome Measures :
  1. Time to Progression
  2. Overall survival
  3. Overall toxicity

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

Inclusion Criteria:

To be included in this study, you must meet the following criteria:

  • Relapsed or Progressive Disease
  • Stage IIIB (not candidate for combined modality) or IV
  • No more than one prior chemotherapy regimen
  • Able to perform activities of daily living without assistance
  • Measurable disease outside of radiation port
  • Adequate bone marrow, liver and kidney function
  • Must understand study and sign informed consent prior to enrollment

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

  • Prior treatment with Topotecan or Docetaxel
  • Uncontrolled brain metastases
  • Moderate peripheral neuropathy

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.

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 identifier (NCT number): NCT00193245

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United States, Tennessee
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37023
Sponsors and Collaborators
SCRI Development Innovations, LLC
Aventis Pharmaceuticals
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Principal Investigator: Howard A. Burris, MD SCRI Development Innovations, LLC

Additional Information:
Publications of Results:
Layout table for additonal information Identifier: NCT00193245    
Other Study ID Numbers: SCRI LUN 47
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: June 28, 2010
Last Verified: January 2009
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors