Study of 0.1% Uracil Topical Cream (UTC) for the Prevention of Hand-Foot Syndrome

Nanometics (d.b.a. PHD Biosciences)18 enrolled

Overview

The purpose of this research study is to see if combining uracil cream (UTC) with capecitabine (Xeloda) can prevent Hand-Foot Syndrome. The study will also see what effects UTC and capecitabine may have in patients with metastatic breast cancer.

Capecitabine is used in the treatment of human breast cancer among other human cancers. Following absorption, capecitabine is converted enzymatically to 5-fluorouracil (5-FU). The administration of capecitabine or 5-FU can cause a cutaneous toxicity known as hand-foot syndrome (HFS) or palmar-plantar erythrodysesthesia (PPE). HFS is progressive with dose and duration of exposure to 5-FU or capecitabine. HFS is characterized by progressive redness and cracking of hands and feet. Currently, there are no approved therapies for HFS.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Palmar-Plantar Erythrodysesthesia Breast Cancer

Interventions

CreamDRUG

Twice daily lotion to prevent HFS

0.1% Uracil CreamDRUG

Twice daily lotion to prevent HFS

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Females, at least 18 years old * Histologically or cytologically confirmed metastatic breast cancer * You also cannot have any ulcerations or open wounds on palms of hands or soles of feet Exclusion Criteria: * Patients who have had chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C)prior to entering the study or if you have not recovered to Grade 1 or better (except for alopecia)from adverse events due to agents administered more than 2 weeks earlier. * Use vitamin 6, chronic use of Cox-2 inhibitors, use full-dose anti- coagulants or use nicotine patches. The above is not a complete list of eligibility criteria. Please see your study doctor for more information.

Locations (6)

Bruno Cancer Center

Birmingham, Alabama, United States

Comprehensive Cancer Center

Palm Springs, California, United States

Research Institute of Deaconess Clinic

Evansville, Indiana, United States

Cancer Care Center

New Albany, Indiana, United States

Outcomes

Primary Outcomes

Incidence of Grade 2 and 3 HFS as graded by Roche Criteria

* Time to first HFS event * Requirements for capecitabine dose reduction/interruption due to HFS * Digital Photos will be taken of the hands and feet at specific intervals

Time frame: Maximum of 6 months of therapy

Serum Pharmacokinetic Levels of Uracil will be drawn

Pharmacokinetic levels will be drawn at specific intervals

Time frame: Maximum of 6 months of therapy

Secondary Outcomes

Anti-Tumor efficacy of Capecitabine

RECIST - Radiologic Criteria for subjects with measurable disease

Time frame: Maximum of 6 months of therapy

Data from ClinicalTrials.gov

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