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Weekly Topotecan in Patients Treated for Metastatic Colorectal Cancer

Sponsor
SCRI Development Innovations, LLC (Other)
Overall Status
Completed
CT.gov ID
NCT00193167
Collaborator
GlaxoSmithKline (Industry)
40
Enrollment
1
Location
27
Duration (Months)
1.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

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

Study Design

Study Type:
Interventional
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase II Study of Weekly Topotecan in Patients Treated for Metastatic Colorectal Cancer
Study Start Date :
Jan 1, 2004
Actual Primary Completion Date :
Apr 1, 2006
Actual Study Completion Date :
Apr 1, 2006

Outcome Measures

Primary Outcome Measures

  1. overall response rate []

Secondary Outcome Measures

  1. median survival []

  2. one year survival []

  3. toxicity []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tennessee Oncology Nashville Tennessee United States 37203

Sponsors and Collaborators

  • SCRI Development Innovations, LLC
  • GlaxoSmithKline

Investigators

  • Principal Investigator: Anthony Greco, MD, SCRI Development Innovations, LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00193167
Other Study ID Numbers:
  • SCRI GI 56
  • 104864724
First Posted:
Sep 19, 2005
Last Update Posted:
May 3, 2011
Last Verified:
May 1, 2011
Additional relevant MeSH terms:
Colorectal Neoplasms
Topotecan

Study Results

No Results Posted as of May 3, 2011