Eniluracil Hand Foot Syndrome

NCT00827580 | Terminated Phase 1 DMC

• 1 other identifier: HS20667
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer; Colon Cancer

Keywords

HFS; patients with breast or colon cancer receiving capecitabine

Outcome Measures

Primary Outcomes (1)

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

Study Arms (1)

Eniluracil

EXPERIMENTAL

Drug: Eniluracil

Interventions

Eniluracil DRUG

Eniluracil

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• West Virginia University: lead

Study Sites (1)

Clinical Trials Research Unit, West Virginia University

Morgantown, West Virginia, 226506, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Colonic Neoplasms

Interventions

eniluracil

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• William P. Petros, Pharm D

  West Virginia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2009
• First Posted: January 23, 2009
• Study Start: January 1, 2009
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: May 30, 2018

Record last verified: 2018-05

Locations

US (1)