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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Palmar-Plantar Erythrodysesthesia
• Intervention / Treatment: Drug: Cream; Drug: 0.1% Uracil Cream

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Bruno Cancer Center
  • California
    • Palm Springs, California, United States, 92262
      • Comprehensive Cancer Center
  • Indiana
    • Evansville, Indiana, United States, 47713
      • Research Institute of Deaconess Clinic
    • New Albany, Indiana, United States, 47150
      • Cancer Care Center
  • Kansas
    • Overland Park, Kansas, United States, 66210
      • Kansas City Cancer Centers
  • Ohio
    • Middleton, Ohio, United States, 45042
      • Signal Point Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Lotion	Drug: Cream; Twice daily lotion to prevent HFS
Experimental: 0.1% Uracil	Drug: 0.1% Uracil Cream; Twice daily lotion to prevent HFS

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Nanometics (d.b.a. PHD Biosciences)
• Investigators: Principal Investigator: James Cantrell, MD, Birmingham Hematology/Oncology Associates

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2010
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: April 6, 2010
• First Submitted That Met QC Criteria: April 8, 2010
• First Posted (Estimate): April 9, 2010

Study Record Updates

• Last Update Posted (Actual): October 8, 2019
• Last Update Submitted That Met QC Criteria: October 5, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: HFS, Hand-Foot Syndrome, Capecitabine, Breast Cancer
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Dermatitis; Drug-Related Side Effects and Adverse Reactions; Drug Eruptions; Drug Hypersensitivity; Breast Neoplasms; Hand-Foot Syndrome
• Other Study ID Numbers: OIC-1UO-C001