Skip to main content
OpenTrials
Completed

NCT Number: NCT00193167

Weekly Topotecan in Patients Treated for Metastatic Colorectal Cancer

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Tennessee Oncology

Nashville, Tennessee, 37203, United States

About this study

Upon determination of eligibility, patients will be receive:

  • Topotecan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Topotecan

Drug

Primary outcomes

  1. overall response rate

Secondary outcomes

  1. median survival

  2. one year survival

  3. toxicity

Sponsors and collaborators

Lead sponsor

SCRI Development Innovations, LLC

Other

Collaborators

  • GlaxoSmithKline

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Sep 19, 2005
Registry last updated
May 3, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.