Eniluracil Hand Foot Syndrome

This study has been completed.
Sponsor:
Collaborator:
Investigator initiated study
Information provided by:
West Virginia University
ClinicalTrials.gov Identifier:
NCT00827580
First received: January 22, 2009
Last updated: August 27, 2009
Last verified: August 2009
  Purpose

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


Condition Intervention Phase
Breast Cancer
Colon Cancer
Drug: Eniluracil
Drug: Capecitabine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Pilot Study of Eniluracil Containing Ointment for Prevention of Hand Foot Syndrome (HRS) Following Capecitabine (Xeloda)

Resource links provided by NLM:


Further study details as provided by West Virginia University:

Primary Outcome Measures:
  • the frequency of HFS; evaluation of eniluracil dose response; and assessment of any toxicity related to the topical product. [ Designated as safety issue: No ]

Estimated Enrollment: 35
Study Start Date: January 2009
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00827580

Locations
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
Investigators
Principal Investigator: William P. Petros, Pharm D West Virginia University
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. William P. Petros, PI, West Virginia University
ClinicalTrials.gov Identifier: NCT00827580     History of Changes
Other Study ID Numbers: HS20667
Study First Received: January 22, 2009
Last Updated: August 27, 2009
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Breast Neoplasms
Hand-Foot Syndrome
Breast Diseases
Chemically-Induced Disorders
Dermatitis
Drug Eruptions
Drug Hypersensitivity
Drug-Related Side Effects and Adverse Reactions
Neoplasms
Neoplasms by Site
Skin Diseases
5-ethynyluracil
Capecitabine
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014