Weekly Topotecan in the Second-Line Treatment of Small Cell Lung Cancer
Phase 2
Completed
- Conditions
- Lung Cancer
- Registration Number
- NCT00193388
- Lead Sponsor
- SCRI Development Innovations, LLC
- Brief Summary
In this phase II trial, we will evaluate the weekly schedule of topotecan in the second-line treatment of patients with small cell lung cancer
- Detailed Description
Upon determination of eligibility, all patients will be receive:
* Topotecan
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
To be included in this study, you must meet the following criteria:
- Small Cell Lung cancer
- Progression after one previous regimen
- Measurable or evaluable disease
- Able to perform activities of daily living with assistance
- Adequate bone marrow, liver and kidney function
- No more than three previous courses of radiation therapy
- Accessible for treatment and follow up
- 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:
- Central nervous system involvement
- Serious or active infection
- Serious underlying medical condition
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Overall response rate
- Secondary Outcome Measures
Name Time Method Median survival 1-year survival Symptomatic improvement