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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Lotion | Placebo Comparator |
| |
| 0.1% Uracil | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cream | Drug | Twice daily lotion to prevent HFS |
| |
| 0.1% Uracil Cream |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Grade 2 and 3 HFS as graded by Roche Criteria |
| Maximum of 6 months of therapy |
| Serum Pharmacokinetic Levels of Uracil will be drawn | Pharmacokinetic levels will be drawn at specific intervals | Maximum of 6 months of therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-Tumor efficacy of Capecitabine | RECIST - Radiologic Criteria for subjects with measurable disease | Maximum of 6 months of therapy |
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Inclusion Criteria:
Exclusion Criteria:
The above is not a complete list of eligibility criteria. Please see your study doctor for more information.
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| Name | Affiliation | Role |
|---|---|---|
| James Cantrell, MD | Birmingham Hematology/Oncology Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bruno Cancer Center | Birmingham | Alabama | 35205 | United States | ||
| Comprehensive Cancer Center |
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| Drug |
Twice daily lotion to prevent HFS |
|
| Palm Springs |
| California |
| 92262 |
| United States |
| Research Institute of Deaconess Clinic | Evansville | Indiana | 47713 | United States |
| Cancer Care Center | New Albany | Indiana | 47150 | United States |
| Kansas City Cancer Centers | Overland Park | Kansas | 66210 | United States |
| Signal Point Clinical Research Center | Middleton | Ohio | 45042 | United States |
| ID | Term |
|---|---|
| D060831 | Hand-Foot Syndrome |
| D001943 | Breast Neoplasms |
| D057770 | Hyaline Fibromatosis Syndrome |
| ID | Term |
|---|---|
| D003875 | Drug Eruptions |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D004342 | Drug Hypersensitivity |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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