Status:
COMPLETED
Topotecan in Combination With Docetaxel in Refractory and/or Advanced Solid Tumors
Lead Sponsor:
SCRI Development Innovations, LLC
Collaborating Sponsors:
GlaxoSmithKline
Genentech, Inc.
Conditions:
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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...
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) an...
Eligibility Criteria
Inclusion
- To be included in this study, you must meet the following criteria:
- Adult \> 18 years of age
- ECOG performance status 0 or 1
- Received 3 or less chemotherapy regimens in the metastatic setting
- Adequate bone marrow, liver and kidney function
- Prior brain metastases must be inactive and asymptomatic
- No previous treatment with Topotecan or docetaxel
- Understand the nature of the study and give written informed consent
Exclusion
- You cannot participate in this study if any of the following apply to you:
- Moderate or severe peripheral neuropathy
- Active concurrent infection or serious underlying medical condition
- Known HIV positivity
- Pregnant or lactating
- 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.
Key Trial Info
Start Date :
February 1 2002
Trial Type :
INTERVENTIONAL
End Date :
January 1 2009
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00193570
Start Date
February 1 2002
End Date
January 1 2009
Last Update
January 23 2009
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