NCT00193245CompletedPhase 2
A Randomized Trial of Oral Topotecan Versus Docetaxel in Second-Line Treatment of Non-Small Cell Lung Cancer
SCRI Development Innovations, LLC2 sites in 1 country80 target enrollmentStarted: November 2000Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 80
- Locations
- 2
- Primary Endpoint
- Overall response rate
Study Overview
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 will receive treatment B (Docetaxel). The study is not blinded so both the patient and the doctor will know which treatment has been assigned.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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.
Outcomes
Primary Outcomes
Overall response rate
Secondary Outcomes
- Time to Progression
- Overall survival
- Overall toxicity
Investigators
Study Sites (2)
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