Weekly Topotecan in Patients Treated for Metastatic Colorectal Cancer

Colon Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00193167
• Other study ID #: SCRI GI 56
• Secondary ID: 104864724
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: May 2, 2011
• Start date: January 2004
• Est. completion date: April 2006

Study information

• 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

Clinical Trial 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 cancer.

Description:

Upon determination of eligibility, patients will be receive:

• Topotecan

Recruitment information / eligibility

• 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.

Study Design

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

Related Conditions & MeSH terms

• Colon Cancer
• Colorectal Neoplasms

Intervention

Drug:
• Topotecan

Locations

Country	Name	City	State
United States	Tennessee Oncology	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
SCRI Development Innovations, LLC	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall response rate
Secondary	median survival
Secondary	one year survival
Secondary	toxicity