Status:
COMPLETED
Weekly Topotecan in Patients Treated for Metastatic Colorectal Cancer
Lead Sponsor:
SCRI Development Innovations, LLC
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Colon Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This non-randomized phase II study is designed to assess the response rate and toxicity of weekly topotecan as second-line treatment in patients with relapsed or refractory metastatic colorectal cance...
Detailed Description
Upon determination of eligibility, patients will be receive: * Topotecan
Eligibility Criteria
Inclusion
- To be included in this study, you must meet the following criteria:
- Metastatic colorectal cancer
- One previous chemotherapy for metastatic disease
- Measurable or evaluable disease
- Able to perform activities of daily living with assistance
- Adequate bone marrow, liver, and kidney function
- All patients must give written informed consent prior to study entry.
Exclusion
- You cannot participate in this study if any of the following apply to you:
- Brain or meningeal involvement
- Serious active infection or underlying medical conditions
- Other active neoplasms are ineligible
- 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 :
January 1 2004
Trial Type :
INTERVENTIONAL
End Date :
April 1 2006
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00193167
Start Date
January 1 2004
End Date
April 1 2006
Last Update
May 3 2011
Active Locations (1)
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1
Tennessee Oncology
Nashville, Tennessee, United States, 37203