View Clinical Trial (Medical Research Study)

A Phase 1-2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetic Profile of 0.1% Uracil Ointment (1UO)in the Prevention of Hand-Foot Syndrome (HFS) in Patients With Metastatic Breast Cancer

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Conditions:		Palmar-Plantar Erythrodysesthesia - Breast Cancer
Purpose:		The purpose of this research study is to see if combining uracil ointment (1UO) with capecitabine (Xeloda) can prevent Hand-Foot Syndrome. The study will also see what effects 1UO and capecitabine may have in patients with metastatic breast cancer.
Study Summary:		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.
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.
NCT ID:		NCT01100463
Primary Contact:		Principal Investigator James Cantrell, MD Birmingham Hematology/Oncology Associates Michael R Myers, BA, MA Phone: 410-889-2221 Email: mmyers@rpsweb.com
Backup Contact:		Email: jstone@rpsweb.com Joi Stone Phone: 866-877-7376 ext. 3710
Location Contact:		Evansville, Indiana 47713 United States Lou Ann Shoaff Phone: 812-426-9390 Email: louann_shoaff@deaconess.com Site Status: Recruiting

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