A Phase I Study of Topotecan in Combination With Docetaxel in Patients With Refractory and/or Advanced Solid Tumors
Upon determination of eligibility, patients will be randomly assigned to one of two
For ever 2 patients treated, 1 will receive treatment A (Paclitaxel + Carboplatin +
Gemcitabine) and 1 will receive treatment B (Gemcitabine + Vinorelbine). The study is not
blinded so both the patient and the doctor will know which treatment has been assigned.
Upon determination of eligibility, patients will be receive:
- Docetaxel + Topotecan
In order to determine the most appropriate dosing regimen to progress into future phase II
trials, two different dosing schedules of Topotecan and docetaxel will be utilized.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine maximum tolerated dose of drug combination
Howard A. Burris, MD
Sarah Cannon Research Institute
United States: Food and Drug Administration
SCRI REFMAL 34