ClinicalTrials.gov
ClinicalTrials.gov Menu

Weekly Topotecan in Patients Treated for Metastatic Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00193167
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : May 3, 2011
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
SCRI Development Innovations, LLC

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
Colon Cancer Drug: Topotecan Phase 2

Detailed Description:

Upon determination of eligibility, patients will be receive:

  • Topotecan

Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
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 : January 2004
Actual Primary Completion Date : April 2006
Actual Study Completion Date : April 2006

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. overall response rate

Secondary Outcome Measures :
  1. median survival
  2. one year survival
  3. toxicity


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00193167


Locations
United States, Tennessee
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

Responsible Party: SCRI Oncology Research Consortium, SCRI
ClinicalTrials.gov Identifier: NCT00193167     History of Changes
Other Study ID Numbers: SCRI GI 56
104864724
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: May 3, 2011
Last Verified: May 2011

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Topotecan
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents