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Weekly Topotecan in Patients Treated for Metastatic Colorectal Cancer

Primary Purpose

Colon Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Topotecan
Sponsored by
SCRI Development Innovations, LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colon Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Tennessee Oncology

Outcomes

Primary Outcome Measures

overall response rate

Secondary Outcome Measures

median survival
one year survival
toxicity

Full Information

First Posted
September 12, 2005
Last Updated
May 2, 2011
Sponsor
SCRI Development Innovations, LLC
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00193167
Brief Title
Weekly Topotecan in Patients Treated for Metastatic Colorectal Cancer
Official Title
Phase II Study of Weekly Topotecan in Patients Treated for Metastatic Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
April 2006 (Actual)
Study Completion Date
April 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
SCRI Development Innovations, LLC
Collaborators
GlaxoSmithKline

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Topotecan
Primary Outcome Measure Information:
Title
overall response rate
Secondary Outcome Measure Information:
Title
median survival
Title
one year survival
Title
toxicity

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony Greco, MD
Organizational Affiliation
SCRI Development Innovations, LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tennessee Oncology
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Weekly Topotecan in Patients Treated for Metastatic Colorectal Cancer

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