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

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cahaba Pharmaceuticals; Nanometics (d.b.a. PHD Biosciences)
• Treatments: Capecitabine

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.