Sorafenib-induced Hand- Foot Skin Reaction Treatment

This study has been terminated.
(Study was halted due to poor subject accrual.)
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Dennis West, Northwestern University
ClinicalTrials.gov Identifier:
NCT00667589
First received: April 24, 2008
Last updated: May 28, 2013
Last verified: May 2013
  Purpose

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


Condition Intervention Phase
Hand-foot Skin Reaction
Rash
Drug: urea 40% cream
Drug: fluocinonide 0.05% cream
Drug: tazarotene 0.1% cream
Drug: bland emollient cream (Udderly smooth® Udder Cream)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Change in Skindex-16 Total Score Between Baseline and 8 Weeks [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
    The Skindex-16 questionnaire contains 16 questions related to quality of life in patients with skin disease. Total scores may range from 0 to 96, where 0 is associated with a better quality of life and 96 is associated with a worse quality of life. The data provided below indicates the change in the Skindex-16 total score between baseline and at 8 weeks.


Secondary Outcome Measures:
  • Change in Skindex-16 Total Score Between Baseline and 2 Weeks [ Time Frame: baseline and 2 weeks ] [ Designated as safety issue: No ]
    The Skindex-16 questionnaire contains 16 questions related to quality of life in patients with skin disease. Total scores may range from 0 to 96, where 0 is associated with a better quality of life and 96 is associated with a worse quality of life. The data provided below indicates the change in the Skindex-16 total score between baseline and at 2 weeks.


Enrollment: 6
Study Start Date: June 2008
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: urea 40% cream Drug: urea 40% cream
urea 40% cream applied twice per day to affected areas
Other Name: carmol 40
Experimental: fluocinonide 0.05% cream Drug: fluocinonide 0.05% cream
fluocinonide 0.05% cream applied twice per day to affected areas
Experimental: tazarotene 0.1% cream Drug: tazarotene 0.1% cream
tazarotene 0.1% cream applied twice per day to affected areas
Other Name: tazarac
Experimental: bland emollient cream Drug: bland emollient cream (Udderly smooth® Udder Cream)
bland emollient cream applied twice per day to affected areas
Other Name: 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 (HFSR), a rash caused by sorafenib.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00667589

Locations
United States, Illinois
Northwestern University Feinberg School of Medicine, Department of Dermatology
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Bayer
Investigators
Principal Investigator: Dennis West, PhD Northwestern University
  More Information

No publications provided

Responsible Party: Dennis West, Professor in Dermatology, Northwestern University
ClinicalTrials.gov Identifier: NCT00667589     History of Changes
Other Study ID Numbers: STU2149
Study First Received: April 24, 2008
Results First Received: February 26, 2013
Last Updated: May 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
sorafenib
rash
hand foot skin reaction

Additional relevant MeSH terms:
Exanthema
Skin Diseases
Emollients
Fluocinonide
Tazarotene
Nicotinic Acids
Sorafenib
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Allergic Agents
Anti-Inflammatory Agents
Keratolytic Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 20, 2014