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Eniluracil Hand Foot Syndrome

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ClinicalTrials.gov Identifier: NCT00827580
Recruitment Status : Completed
First Posted : January 23, 2009
Last Update Posted : August 28, 2009
Investigator initiated study
Information provided by:
West Virginia University

Brief Summary:
A pilot study of eniluracil containing ointment for prevention of hand foot syndrome (HRS) following capecitabine (Xeloda).

Condition or disease Intervention/treatment Phase
Breast Cancer Colon Cancer Drug: Eniluracil Drug: Capecitabine Phase 1

Detailed Description:

Primary Objectives

  1. To estimate the frequency of HFS following treatment with capecitabine as modulated by the unilateral local application of eniluracil containing ointment.
  2. To assess any eniluracil dose response relationship in prevention of HFS.
  3. To evaluate any potential toxicity of eniluracil ointment.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Pilot Study of Eniluracil Containing Ointment for Prevention of Hand Foot Syndrome (HRS) Following Capecitabine (Xeloda)
Study Start Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health
U.S. FDA Resources

Primary Outcome Measures :
  1. the frequency of HFS; evaluation of eniluracil dose response; and assessment of any toxicity related to the topical product.

Information from the National Library of Medicine

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

Inclusion Criteria:

A subject will be eligible for inclusion in this study ONLY if ALL of the following criteria apply:

  1. Signed written informed consent.
  2. Male or female, at least 18 years of age.
  3. Histologically or cytologically confirmed diagnosis of breast or colon cancer.
  4. Radiologically documented measurable disease
  5. Planned to receive capecitabine at 1000-1250 mg/m2 PO twice daily and has experienced grade 1 or greater HFS on a previous cycle of capecitabine.
  6. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 at study entry.
  7. Adequate liver function with SGOT and SGPT < 2.5 times upper limits of normal.
  8. Adequate bone marrow function evidence by WBC > 2500/mm3, PMN >2000/mm3 and platelet count > 100,000/mm3.
  9. Adequate renal function with serum creatinine < 1.7 mg/dl.
  10. Recovery from relevant toxicity before study entry.
  11. Negative serum or urine pregnancy test within 7 days before study entry for women of childbearing potential. Effective contraception throughout the course of the study for both male and female subjects if the risk of conception exists.

Exclusion Criteria:

A subject will not be eligible for inclusion in this study if ANY of the following criteria apply:

  1. Known DPD deficiency
  2. Any other investigational drug, chronic corticosteroids or radiation therapy within 28 days before study entry.
  3. History of brain metastases or spinal cord compression, unless irradiated at least 28 days before study entry and stable without steroid treatment for >28 days.
  4. Stroke, major surgery, or other major tissue injury within 30 days before study entry.
  5. Myocardial infarction within 12 months or uncontrolled congestive heart failure, angina, arrhythmias, or ECG abnormalities.
  6. No concurrent or planned use of topical pharmaceuticals to the hands or feet other than Aquaphor®.
  7. No concurrent or planned use of cytotoxic drugs (other than capecitabine).
  8. No other dermatologic condition that may complicate evaluation of the study.
  9. Other uncontrolled serious chronic disease or conditions that in the investigator's opinion could render compliance or follow-up in the protocol problematic.
  10. Breast feeding or lactating.
  11. Unable to return at the regular required intervals for reassessment or study drug administration.
  12. Legal incapacity or limited legal capacity, unless authorization is granted by a legal guardian.
  13. Allergy to lanolin

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): NCT00827580

United States, West Virginia
Clinical Trials Research Unit, West Virginia University
Morgantown, West Virginia, United States, 226506
Sponsors and Collaborators
West Virginia University
Investigator initiated study
Principal Investigator: William P. Petros, Pharm D West Virginia University

Responsible Party: Dr. William P. Petros, PI, West Virginia University
ClinicalTrials.gov Identifier: NCT00827580     History of Changes
Other Study ID Numbers: HS20667
First Posted: January 23, 2009    Key Record Dates
Last Update Posted: August 28, 2009
Last Verified: August 2009

Keywords provided by West Virginia University:
patients with breast or colon cancer receiving capecitabine

Additional relevant MeSH terms:
Colonic Neoplasms
Hand-Foot Syndrome
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Drug Eruptions
Skin Diseases
Drug Hypersensitivity
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors