Eniluracil Hand Foot Syndrome

A Pilot Study of Eniluracil Containing Ointment for Prevention of Hand Foot Syndrome (HRS) Following Capecitabine (Xeloda)

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

Study Overview

• Status: Terminated
• Conditions: Breast Cancer; Colon Cancer
• Intervention / Treatment: Drug: Eniluracil

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
• Enrollment (Actual): 3
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • West Virginia
    • Morgantown, West Virginia, United States, 226506
      • Clinical Trials Research Unit, West Virginia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Eniluracil	Drug: Eniluracil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
the frequency of HFS; evaluation of eniluracil dose response; and assessment of any toxicity related to the topical product.

Collaborators and Investigators

• Sponsor: West Virginia University
• Investigators: Principal Investigator: William P. Petros, Pharm D, West Virginia University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2009
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: January 22, 2009
• First Submitted That Met QC Criteria: January 22, 2009
• First Posted (Estimate): January 23, 2009

Study Record Updates

• Last Update Posted (Actual): May 30, 2018
• Last Update Submitted That Met QC Criteria: May 25, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: HFS; patients with breast or colon cancer receiving capecitabine
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Digestive System Diseases; Skin Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Dermatitis; Drug-Related Side Effects and Adverse Reactions; Drug Eruptions; Drug Hypersensitivity; Colonic Neoplasms; Hand-Foot Syndrome; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Eniluracil
• Other Study ID Numbers: HS20667