Status:
COMPLETED
Weekly Topotecan in Combination With Carboplatin in Two Different Schedules for Refractory and/or Advanced Solid Tumors
Lead Sponsor:
SCRI Development Innovations, LLC
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
In this phase I study we will characterize the safety, tolerability, maximum tolerated dose and dose-limiting toxicity of weekly bolus topotecan when administered in combination with two different dos...
Detailed Description
Upon determination of eligibility, patients will be receive: * Topotecan + Carboplatin In order to determine the most appropriate dosing regimen to progress into future phase II trials, two differen...
Eligibility Criteria
Inclusion
- To be included in this study, you must meet the following criteria:
- Adult patients at least 18 years old
- Advanced solid tumors refractory to conventional therapy
- ECOG performance status must be 0 or 1
- Patients may have received no more than 3 prior chemotherapy regimens
- Adequate bone marrow, liver and kidney function
- Able to 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:
- Active concurrent infections or serious underlying medical conditions
- Known HIV positivity
- Female patients who are pregnant or lactating
- Received both topotecan and carboplatin
- 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 :
May 1 2003
Trial Type :
INTERVENTIONAL
End Date :
May 1 2005
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00193583
Start Date
May 1 2003
End Date
May 1 2005
Last Update
May 4 2011
Active Locations (1)
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1
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37023