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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase 1-2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetic Profile of 0.1% Uracil Topical Cream (UTC) in the Prevention of Hand-Foot Syndrome (HFS) in Patients With Metastatic Breast Cancer Treated With Capecitabine

Conditions
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Palmar-Plantar Erythrodysesthesia, Breast Cancer

Intervention / Treatment
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* Drug: Cream
* Drug: 0.1% Uracil Cream


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo Lotion<br> | Drug: Cream<br>* Twice daily lotion to prevent HFS<br>|
| Experimental: 0.1% Uracil<br> | Drug: 0.1% Uracil Cream<br>* Twice daily lotion to prevent HFS<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Maximum of 6 months of therapy | 
| Serum Pharmacokinetic Levels of Uracil will be drawn | Pharmacokinetic levels will be drawn at specific intervals | Maximum of 6 months of therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-Tumor efficacy of Capecitabine | RECIST - Radiologic Criteria for subjects with measurable disease | Maximum of 6 months of therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HFS, Hand-Foot Syndrome, Capecitabine, Breast Cancer