Status:
TERMINATED
Sorafenib-induced Hand- Foot Skin Reaction Treatment
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
Bayer
Conditions:
Hand-foot Skin Reaction
Rash
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate treatments for a rash caused by sorafenib.
Detailed Description
This study will compare compare the effectiveness of four creams (urea 40% cream, fluocinonide 0.05% cream, tazarotene 0.1% cream, and Udderly smooth® Udder Cream) in treating hand-foot skin reaction ...
Eligibility Criteria
Inclusion
- Patients receiving sorafenib as monotherapy or in combination if other agents are not known to cause HFSR.
- Subjects must be 18 years or older.
- Patients must provide written informed consent to participate in the study.
- Women of childbearing potential and men must be willing to use an effective method of contraception while participating in this study and for at least two weeks after completing treatment in the study.
- Women in this study need to have a negative urine pregnancy test before starting study medications.
Exclusion
- Patients simultaneously taking another anti-cancer agent or combination of anti-cancer agents known to cause hand foot syndrome (pegylated doxorubicin, 5-fluorouracil, cytarabine).
- Patients with an active dermatological condition due to previous chemotherapy or biologic therapy affecting the hands.
- Patients with pre-existing dermatological condition affecting the hands or feet.
- Women who have a positive pregnancy test or are lactating.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00667589
Start Date
June 1 2008
End Date
December 1 2010
Last Update
June 5 2013
Active Locations (1)
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1
Northwestern University Feinberg School of Medicine, Department of Dermatology
Chicago, Illinois, United States, 60611