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

Phase 1

Completed

• Conditions: Palmar-Plantar Erythrodysesthesia; Breast Cancer
• Interventions: Drug: Cream; Drug: 0.1% Uracil Cream

• Registration Number: NCT01100463
• Lead Sponsor: Nanometics (d.b.a. PHD Biosciences)

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.

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-04-06
• Study First Submitted QC: 2010-04-08
• Study First Posted: 2010-04-09
• Primary Completion: 2011-08
• Study Completion: 2011-09
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-05
• Last Update Posted: 2019-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 18

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Lotion	Cream	-
0.1% Uracil	0.1% Uracil Cream	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Anti-Tumor efficacy of Capecitabine	Maximum of 6 months of therapy	RECIST - Radiologic Criteria for subjects with measurable disease

Trial Locations

Locations (6)

Kansas City Cancer Centers; 🇺🇸 Overland Park, Kansas, United States

Comprehensive Cancer Center; 🇺🇸 Palm Springs, California, United States

Bruno Cancer Center; 🇺🇸 Birmingham, Alabama, United States

Research Institute of Deaconess Clinic; 🇺🇸 Evansville, Indiana, United States

Cancer Care Center; 🇺🇸 New Albany, Indiana, United States

Signal Point Clinical Research Center; 🇺🇸 Middleton, Ohio, United States