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

Phase 1
18 Years
Not Enrolling
Breast Cancer, Colon Cancer

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Trial Information

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

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.

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

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

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

12. Legal incapacity or limited legal capacity, unless authorization is granted by a
legal guardian.

13. Allergy to lanolin

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

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

Safety Issue:


Principal Investigator

William P. Petros, Pharm D

Investigator Role:

Principal Investigator

Investigator Affiliation:

West Virginia University


United States: Food and Drug Administration

Study ID:




Start Date:

January 2009

Completion Date:

Related Keywords:

  • Breast Cancer
  • Colon Cancer
  • HFS
  • patients with breast or colon cancer receiving capecitabine
  • Breast Neoplasms
  • Colonic Neoplasms



Clinical Trials Research Unit, West Virginia University Morgantown, West Virginia  26506-9260