Weekly Topotecan in the First-line Treatment of Elderly Patients With Small Cell Lung Cancer
- Conditions
- Lung Cancer
- Registration Number
- NCT00193401
- Lead Sponsor
- SCRI Development Innovations, LLC
- Brief Summary
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
- Detailed Description
Upon determination of eligibility, all patients will be receive:
* Topotecan
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
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.
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.
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 and 2 year survival Overall toxicity