Lung Cancer
Conditions
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.
Interventions
DRUGTopotecan
DRUGDocetaxel
Sponsors
AstraZeneca
Aventis Pharmaceuticals
GlaxoSmithKline
SCRI Development Innovations, LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
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: * 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to Progression | — |
| Overall survival | — |
| Overall toxicity | — |
Countries
United States
Outcome results
None listed