Topotecan in Combination With Docetaxel in Refractory and/or Advanced Solid Tumors
This phase I study will characterize the safety, tolerability, and maximum tolerated dose and dose-limiting toxicity of weekly bolus Topotecan when administered in combination with to different dosing regimens of docetaxel. We will also evaluate any anti-tumor activity of the combination regimen.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Study of Topotecan in Combination With Docetaxel in Patients With Refractory and/or Advanced Solid Tumors|
- Determine maximum tolerated dose of drug combination
- Response rates
|Study Start Date:||February 2002|
|Study Completion Date:||January 2009|
|Primary Completion Date:||August 2004 (Final data collection date for primary outcome measure)|
Upon determination of eligibility, patients will be randomly assigned to one of two treatment arms:
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00193570
|Principal Investigator:||Howard A. Burris, MD||SCRI Development Innovations, LLC|