Sorafenib-induced Hand- Foot Skin Reaction Treatment

Condition(s) targeted: Hand-foot Skin Reaction; Rash

Intervention: urea 40% cream (Drug); fluocinonide 0.05% cream (Drug); tazarotene 0.1% cream (Drug); bland emollient cream (Udderly smooth® Udder Cream) (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Northwestern University

Official(s) and/or principal investigator(s):
Jonathan Cotliar, MD, Principal Investigator, Affiliation: Northwestern University

Overall contact:
Marcy Urbanich, Phone: 312-695-6829, Email: m-urbanich@northwestern.edu

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

Official title: Four-arm Study to Evaluate Urea 40% Cream, Fluocinonide 0.05% Cream, Tazarotene 0.1% Cream, and an Emollient Cream for the Treatment of Hand-foot Skin Reaction Related to the Use of Multi-targeted Tyrosine Kinase Inhibitor Sorafenib.

Study design: Allocation: Randomized, Control: Uncontrolled, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

To compare the duration of HFSR for subjects receiving urea 40% cream, fluocinonide 0.05% cream, tazarotene 0.1% cream, and Udderly smooth® Udder Cream

To compare patient reported outcomes for subjects receiving urea 40% cream, fluocinonide 0.05% cream, tazarotene 0.1% cream, and Udderly smooth® Udder Cream

Secondary outcome:

To compare subjective (Skindex 16) and objective (NCI-CTC AE) clinical responses to urea 40% cream, fluocinonide 0.05% cream, tazarotene 0.1% cream, and Udderly smooth® Udder Cream.

To produce a photographic collection of HFSR severity in sorafenib and responses to urea 40% cream, fluocinonide 0.05% cream, tazarotene 0.1% cream, and Udderly smooth® Udder Cream.

Determine the severity of HFSR in patients treated with urea 40% cream, fluocinonide 0.05% cream, tazarotene 0.1% cream, and Udderly smooth® Udder Cream

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, a rash caused by sorafenib.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Marcy Urbanich, Phone: 312-695-6829, Email: m-urbanich@northwestern.edu

Northwestern University, Chicago, Illinois 60611, United States; Recruiting
Mario Lacouture, MD, Principal Investigator
Alfred Rademaker, PhD, Sub-Investigator
Dennis P West, PhD, Sub-Investigator

Starting date: June 2008
Last updated: September 7, 2010