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.”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Uncontrolled, Parallel Assignment, Efficacy Study

Study Primary Completion Date: December 2009

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.

Intervention(s) in this Clinical Trial

• Drug: urea 40% cream
  • urea 40% cream applied twice per day to affected areas
• Drug: fluocinonide 0.05% cream
  • fluocinonide 0.05% cream applied twice per day to affected areas
• Drug: tazarotene 0.1% cream
  • tazarotene 0.1% cream applied twice per day to affected areas
• Drug: bland emolient cream (Udderly smooth® Udder Cream)
  • bland emolient cream applied twice per day to affected areas

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Experimental: 2
• Experimental: 3
• Experimental: 4

Primary Measures

• 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
  • Time Frame: 8 weeks
    Safety Issue?: No
• To compare patient reported outcomes for subjects receiving urea 40% cream, fluocinonide 0.05% cream, tazarotene 0.1% cream, and Udderly smooth® Udder Cream
  • Time Frame: 8 weeks
    Safety Issue?: No

Secondary Measures

• 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.
  • Time Frame: 8 weeks
    Safety Issue?: No
• 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.
  • Time Frame: 8 weeks
    Safety Issue?: No
• 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
  • Time Frame: 8 weeks
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Northwestern University

Overall Clinical Trial Officials and Contacts

Mario Lacouture, MD Principal Investigator Northwestern University  

Overall Contact: Mona Gandhi, MD 312-695-0287 mona-gandhi@northwestern.edu

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00667589

Study ID Number: NU 07CC5

ClinicalTrials.gov Identifier: NCT00667589

Health Authority: United States: Institutional Review Board