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

SCRI Development Innovations, LLC1 site in 1 country40 target enrollmentJanuary 2004

ConditionsColon Cancer

DrugsTopotecan

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Colon Cancer
Sponsor: SCRI Development Innovations, LLC
Enrollment: 40
Locations: 1
Primary Endpoint: overall response rate
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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 cancer.

Detailed Description

Upon determination of eligibility, patients will be receive: * Topotecan

Registry

clinicaltrials.gov

Start Date

January 2004

End Date

April 2006

Last Updated

15 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

SCRI Development Innovations, LLC

Eligibility Criteria

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.