Clinical trial NCT01100463: Study of 0.1% Uracil Topical Cream (UTC) for the Prevention of Hand-Foot Syndrome
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Palmar-Plantar Erythrodysesthesia
Breast Cancer
Keywords: HFS, Hand-Foot Syndrome, Capecitabine, Breast Cancer
Lead sponsor: Nanometics (d.b.a. PHD Biosciences)
Sponsor class: INDUSTRY
First posted: 2010-04-09
Enrollment: 18
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of Grade 2 and 3 HFS as graded by Roche Criteria
timeFrame: Maximum of 6 months of therapy
measure: Serum Pharmacokinetic Levels of Uracil will be drawn
timeFrame: Maximum of 6 months of therapy
Secondary outcomes:
measure: Anti-Tumor efficacy of Capecitabine
timeFrame: Maximum of 6 months of therapy
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Bruno Cancer Center
state: Alabama
city: Palm Springs
country: United States
facility: Comprehensive Cancer Center
state: California
city: Evansville
country: United States
facility: Research Institute of Deaconess Clinic
state: Indiana
city: New Albany
country: United States
facility: Cancer Care Center
state: Indiana
city: Overland Park
country: United States
facility: Kansas City Cancer Centers
state: Kansas
city: Middleton
country: United States
facility: Signal Point Clinical Research Center
state: Ohio
Study officials:
affiliation: Birmingham Hematology/Oncology Associates
name: James Cantrell, MD
role: PRINCIPAL_INVESTIGATOR
References: