A Phase 1 interventional study of Topotecan and Docetaxel in Cancer, sponsored by SCRI Development Innovations, LLC. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-01-23.
Sponsored by SCRI Development Innovations, LLC · Phase 1, Interventional, and Treatment
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.
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:
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.
SCRI Development Innovations, LLC is the lead sponsor of 174 studies on the registry; 5 are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 15 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
To be included in this study, you must meet the following criteria:
Exclusion Criteria:
You cannot participate in this study if any of the following apply to you:
Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
Determine maximum tolerated dose of drug combination
Response rates
No study locations are listed for this record.
This study is completed, as verified in Jan 2009. You cannot join it, but the record below documents what was studied.
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SCRI Development Innovations, LLC