Weekly Topotecan in Patients Treated for Metastatic Colorectal Cancer

Phase II Study of Weekly Topotecan in Patients Treated for Metastatic Colorectal Cancer

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.

Upon determination of eligibility, patients will be receive:

• Topotecan

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.