Sorafenib-induced Hand- Foot Skin Reaction Treatment

• Status: Terminated
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate treatments for a rash caused by sorafenib.

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

Details

• Lead Sponsor: Northwestern University
• Collaborator: Bayer
• Treatments: Emollients; Fluocinonide; Nicotinic Acids; Sorafenib; Tazarotene

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.