Weekly Topotecan in Patients Treated for Metastatic Colorectal Cancer

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators:	Sarah Cannon Research Institute GlaxoSmithKline
Information provided by:	Sarah Cannon Research Institute
ClinicalTrials.gov Identifier:	NCT00193167

Purpose

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	Intervention	Phase
Colon Cancer	Drug: Topotecan	Phase II

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Topotecan hydrochloride Topotecan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase II Study of Weekly Topotecan in Patients Treated for Metastatic Colorectal Cancer

Further study details as provided by Sarah Cannon Research Institute:

Primary Outcome Measures:

overall response rate

Secondary Outcome Measures:

median survival
one year survival
toxicity

Estimated Enrollment:	40
Study Start Date:	January 2004

Detailed Description:

Upon determination of eligibility, patients will be receive:

Topotecan

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00193167

Locations

United States, Tennessee
Tennessee Oncology
Nashville, Tennessee, United States, 37203

Sponsors and Collaborators

Sarah Cannon Research Institute

GlaxoSmithKline

Investigators

Principal Investigator:

Anthony Greco, MD

Sarah Cannon Research Institute

More Information

Study ID Numbers:	SCRI GI 56, 104864724
Study First Received:	September 12, 2005
Last Updated:	October 2, 2007
ClinicalTrials.gov Identifier:	NCT00193167
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Gastrointestinal Neoplasms
Topotecan

Intestinal Diseases
Rectal Diseases
Colonic Neoplasms
Intestinal Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

Therapeutic Uses
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009