Eniluracil Hand Foot Syndrome
This study has been completed.
Sponsor:
West Virginia University
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
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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:
Genetics Home Reference related topics:
breast cancer
Drug Information available for:
Capecitabine
U.S. FDA Resources
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 |
Primary Objectives
- To estimate the frequency of HFS following treatment with capecitabine as modulated by the unilateral local application of eniluracil containing ointment.
- To assess any eniluracil dose response relationship in prevention of HFS.
- 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:
- Signed written informed consent.
- Male or female, at least 18 years of age.
- Histologically or cytologically confirmed diagnosis of breast or colon cancer.
- Radiologically documented measurable disease
- 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.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 at study entry.
- Adequate liver function with SGOT and SGPT < 2.5 times upper limits of normal.
- Adequate bone marrow function evidence by WBC > 2500/mm3, PMN >2000/mm3 and platelet count > 100,000/mm3.
- Adequate renal function with serum creatinine < 1.7 mg/dl.
- Recovery from relevant toxicity before study entry.
- 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:
- Known DPD deficiency
- Any other investigational drug, chronic corticosteroids or radiation therapy within 28 days before study entry.
- 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.
- Stroke, major surgery, or other major tissue injury within 30 days before study entry.
- Myocardial infarction within 12 months or uncontrolled congestive heart failure, angina, arrhythmias, or ECG abnormalities.
- No concurrent or planned use of topical pharmaceuticals to the hands or feet other than Aquaphor®.
- No concurrent or planned use of cytotoxic drugs (other than capecitabine).
- No other dermatologic condition that may complicate evaluation of the study.
- Other uncontrolled serious chronic disease or conditions that in the investigator's opinion could render compliance or follow-up in the protocol problematic.
- Breast feeding or lactating.
- Unable to return at the regular required intervals for reassessment or study drug administration.
- Legal incapacity or limited legal capacity, unless authorization is granted by a legal guardian.
- Allergy to lanolin
Contacts and Locations
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 Colonic Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases |
Colonic Diseases Intestinal Diseases 5-ethynyluracil Capecitabine Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antimetabolites, Antineoplastic Antimetabolites Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013