Colon Cancer Clinical Trial
Official title:
Phase II Study of Weekly Topotecan in Patients Treated for Metastatic Colorectal Cancer
Verified date | May 2011 |
Source | SCRI Development Innovations, LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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 cancer.
Status | Completed |
Enrollment | 40 |
Est. completion date | April 2006 |
Est. primary completion date | April 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 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 Criteria: 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. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Tennessee Oncology | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
SCRI Development Innovations, LLC | GlaxoSmithKline |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | overall response rate | |||
Secondary | median survival | |||
Secondary | one year survival | |||
Secondary | toxicity |
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