Trials / Completed
CompletedNCT00193570
Topotecan in Combination With Docetaxel in Refractory and/or Advanced Solid Tumors
A Phase I Study of Topotecan in Combination With Docetaxel in Patients With Refractory and/or Advanced Solid Tumors
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (planned)
- Sponsor
- SCRI Development Innovations, LLC · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Topotecan | |
| DRUG | Docetaxel |
Timeline
- Start date
- 2002-02-01
- Primary completion
- 2004-08-01
- Completion
- 2009-01-01
- First posted
- 2005-09-19
- Last updated
- 2009-01-23
Source: ClinicalTrials.gov record NCT00193570. Inclusion in this directory is not an endorsement.