Spots Global Cancer Trial Database for Topotecan in Combination With Docetaxel in Refractory and/or Advanced Solid Tumors
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Trial Identification
Brief Title: Topotecan in Combination With Docetaxel in Refractory and/or Advanced Solid Tumors
Official Title: A Phase I Study of Topotecan in Combination With Docetaxel in Patients With Refractory and/or Advanced Solid Tumors
Study ID: NCT00193570
Conditions
Study Description
Brief Summary: 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.
Detailed Description: 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Contact Details
Name: Howard A. Burris, MD
Affiliation: SCRI Development Innovations, LLC
Role: PRINCIPAL_INVESTIGATOR
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