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

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01100463

Enrollment

Registered

2010-04-09

Start date

2010-04-30

Completion date

2011-09-30

Last updated

2019-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Palmar-Plantar Erythrodysesthesia, Breast Cancer

Keywords

HFS, Hand-Foot Syndrome, Capecitabine, Breast Cancer

Brief summary

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

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.

Interventions

DRUGCream

Twice daily lotion to prevent HFS

DRUG0.1% Uracil Cream

Twice daily lotion to prevent HFS

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Incidence of Grade 2 and 3 HFS as graded by Roche Criteria	Maximum of 6 months of therapy	* 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
Serum Pharmacokinetic Levels of Uracil will be drawn	Maximum of 6 months of therapy	Pharmacokinetic levels will be drawn at specific intervals

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026