NCT01100463

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
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Nanometics (d.b.a. PHD Biosciences) · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Palmar-Plantar Erythrodysesthesia
• Breast Cancer

Interventions

Type	Name	Description
DRUG	Cream	Twice daily lotion to prevent HFS
DRUG	0.1% Uracil Cream	Twice daily lotion to prevent HFS

Timeline

• Start date: 2010-04-01
• Primary completion: 2011-08-01
• Completion: 2011-09-01
• First posted: 2010-04-09
• Last updated: 2019-10-08

Locations

6 sites across 1 country: United States