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
| City: |
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New Albany |
| State: |
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Indiana |
| Zip Code: |
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47150 |
| Conditions: |
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Palmar-Plantar Erythrodysesthesia - Breast Cancer |
| Purpose: |
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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.
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| Study Summary: |
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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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| Criteria: |
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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.
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| NCT ID: |
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NCT01100463 |
| Primary Contact: |
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Principal Investigator
James Cantrell, MD
Birmingham Hematology/Oncology Associates
Michael R Myers, BA, MA
Phone: 410-889-2221
Email: mmyers@rpsweb.com
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| Backup Contact: |
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Email: jstone@rpsweb.com
Joi Stone
Phone: 866-877-7376 ext. 3710
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| Location Contact: |
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New Albany, Indiana 47150
United States
Denette Grider, RN
Phone: 812-945-4000
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 18, 2013 |
| Modifications to this listing: |
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