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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01100463
• Other study ID #: OIC-1UO-C001
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: April 2010
• Est. completion date: September 2011

Study information

• Verified date: October 2019
• Source: Nanometics LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: September 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Hand-Foot Syndrome
• Palmar-Plantar Erythrodysesthesia

Intervention

Drug:
• Cream
Twice daily lotion to prevent HFS
• 0.1% Uracil Cream
Twice daily lotion to prevent HFS

Locations

Country	Name	City	State
United States	Bruno Cancer Center	Birmingham	Alabama
United States	Research Institute of Deaconess Clinic	Evansville	Indiana
United States	Signal Point Clinical Research Center	Middleton	Ohio
United States	Cancer Care Center	New Albany	Indiana
United States	Kansas City Cancer Centers	Overland Park	Kansas
United States	Comprehensive Cancer Center	Palm Springs	California

Sponsors (1)

Lead Sponsor	Collaborator
Nanometics LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Serum Pharmacokinetic Levels of Uracil will be drawn	Pharmacokinetic levels will be drawn at specific intervals	Maximum of 6 months of therapy
Secondary	Anti-Tumor efficacy of Capecitabine	RECIST - Radiologic Criteria for subjects with measurable disease	Maximum of 6 months of therapy