Lung Cancer
Conditions
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
Interventions
DRUGTopotecan
Sponsors
Institutional Review Board TriStar Nashville Market
SCRI Development Innovations, LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Median survival | — |
| 1 year and 2 year survival | — |
| Overall toxicity | — |
Outcome results
None listed