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Sponsors and Collaborators: |
West Virginia University Investigator-Initiated, funding provided by Adherex |
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Information provided by: | West Virginia University |
ClinicalTrials.gov Identifier: | NCT00827580 |
A pilot study of eniluracil containing ointment for prevention of hand foot syndrome (HRS) following capecitabine (Xeloda).
Condition | Intervention | Phase |
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Breast Cancer Colon Cancer |
Drug: Eniluracil Drug: Capecitabine |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study |
Official Title: | A Pilot Study of Eniluracil Containing Ointment for Prevention of Hand Foot Syndrome (HRS) Following Capecitabine (Xeloda) |
Estimated Enrollment: | 35 |
Study Start Date: | January 2009 |
Primary Objectives
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
A subject will be eligible for inclusion in this study ONLY if ALL of the following criteria apply:
Exclusion Criteria:
A subject will not be eligible for inclusion in this study if ANY of the following criteria apply:
United States, West Virginia | |
Clinical Trials Research Unit, West Virginia University | |
Morgantown, West Virginia, United States, 226506 |
Principal Investigator: | William P. Petros, Pharm D | West Virginia University |
Responsible Party: | West Virginia University ( Dr. William P. Petros, PI ) |
Study ID Numbers: | HS20667 |
Study First Received: | January 22, 2009 |
Last Updated: | August 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00827580 History of Changes |
Health Authority: | United States: Food and Drug Administration |
HFS patients with breast or colon cancer receiving capecitabine |
Antimetabolites Capecitabine Digestive System Neoplasms Skin Diseases Gastrointestinal Diseases Colonic Diseases 5-ethynyluracil Breast Neoplasms |
Intestinal Diseases Intestinal Neoplasms Digestive System Diseases Gastrointestinal Neoplasms Colonic Neoplasms Breast Diseases Colorectal Neoplasms |
Antimetabolites Capecitabine Antimetabolites, Antineoplastic Digestive System Neoplasms Molecular Mechanisms of Pharmacological Action Skin Diseases Antineoplastic Agents Gastrointestinal Diseases Colonic Diseases 5-ethynyluracil Breast Neoplasms Enzyme Inhibitors |
Intestinal Diseases Pharmacologic Actions Intestinal Neoplasms Neoplasms Neoplasms by Site Digestive System Diseases Therapeutic Uses Gastrointestinal Neoplasms Colonic Neoplasms Breast Diseases Colorectal Neoplasms |