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


Phase 2
18 Years
N/A
Not Enrolling
Both
Colon Cancer

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Trial Information

Phase II Study of Weekly Topotecan in Patients Treated for 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

overall response rate

Principal Investigator

Anthony Greco, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sarah Cannon Research Institute

Authority:

United States: Institutional Review Board

Study ID:

SCRI GI 56

NCT ID:

NCT00193167

Start Date:

January 2004

Completion Date:

April 2006

Related Keywords:

  • Colon Cancer
  • Colonic Neoplasms
  • Colorectal Neoplasms

Name

Location

Tennessee Oncology Nashville, Tennessee  37203