Sorafenib-induced Hand- Foot Skin Reaction Treatment - Full Text View

Sponsor:	Northwestern University
Information provided by:	Northwestern University
ClinicalTrials.gov Identifier:	NCT00667589

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 II

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

MedlinePlus related topics: Foot Health Rashes

Drug Information available for: Carbamide Tazarotene Sorafenib Sorafenib tosylate Carbamide peroxide Fluocinonide

U.S. FDA Resources

Further study details as provided by Northwestern University:

Primary Outcome 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 ] [ Designated as 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 ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	June 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: urea 40% cream urea 40% cream applied twice per day to affected areas
2: Experimental	Drug: fluocinonide 0.05% cream fluocinonide 0.05% cream applied twice per day to affected areas
3: Experimental	Drug: tazarotene 0.1% cream tazarotene 0.1% cream applied twice per day to affected areas
4: Experimental	Drug: bland emollient cream (Udderly smooth® Udder Cream) bland emollient cream applied twice per day to affected areas

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.

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

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

Contacts

Contact: Marcy Urbanich	312-695-6829	m-urbanich@northwestern.edu
Contact: Jennifer Hensley, MD	312-695-0287	j-hensley@northwestern.edu

Locations

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

Sponsors and Collaborators

Northwestern University

Investigators

Principal Investigator:

Mario Lacouture, MD

Northwestern University

More Information

No publications provided

Responsible Party:	Northwestern University ( Mario Lacouture )
Study ID Numbers:	NU 07CC5
Study First Received:	April 24, 2008
Last Updated:	November 19, 2009
ClinicalTrials.gov Identifier:	NCT00667589 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Northwestern University:

sorafenib
rash
hand foot skin reaction

Additional relevant MeSH terms:

Sorafenib
Anti-Inflammatory Agents
Tazarotene
Vitamin B Complex
Fluocinonide
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Enzyme Inhibitors
Anti-Allergic Agents

Protein Kinase Inhibitors
Glucocorticoids
Hormones
Pharmacologic Actions
Keratolytic Agents
Nicotinic Acids
Vitamins
Therapeutic Uses
Micronutrients
Dermatologic Agents
Emollients

ClinicalTrials.gov processed this record on February 08, 2010