Status:
COMPLETED
Oral Topotecan Versus Docetaxel in Second-Line Treatment of Non-Small Cell Lung Cancer
Lead Sponsor:
SCRI Development Innovations, LLC
Collaborating Sponsors:
AstraZeneca
Aventis Pharmaceuticals
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2000
Trial Type :
INTERVENTIONAL
End Date :
January 1 2009
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00193245
Start Date
November 1 2000
End Date
January 1 2009
Last Update
June 28 2010
Active Locations (1)
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1
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37023