Topical Sunscreen in Preventing Skin Rash in Patients Receiving Drugs Such as Erlotinib or Cetuximab for Cancer - Full Text View

Sponsor:	North Central Cancer Treatment Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00362986

Purpose

RATIONALE: Topical sunscreen may be effective in preventing skin rash caused by treatment with drugs such as erlotinib or cetuximab. It is not yet known whether topical sunscreen is more effective than a placebo in preventing skin rash in patients receiving drugs such as erlotinib or cetuximab for cancer.

PURPOSE: This randomized phase III trial is studying topical sunscreen to see how well it works compared with a placebo in preventing skin rash in patients receiving drugs such as erlotinib or cetuximab for cancer.

Condition	Intervention	Phase
Dermatologic Complications Unspecified Adult Solid Tumor, Protocol Specific	Biological: cetuximab Biological: matuzumab Biological: panitumumab Drug: canertinib dihydrochloride Drug: erlotinib hydrochloride Drug: gefitinib Drug: titanium dioxide/zinc oxide sunscreen cream SPF 60	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Masking: Double-Blind Primary Purpose: Supportive Care
Official Title:	A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial of Prophylactic Topical Sunscreen to Prevent Erlotinib- or Cetuximab-Induced Skin Rash [or Other Epidermal Growth Factor Receptor (EGFR) Inhibitor-Induced Skin Rash]

Resource links provided by NLM:

MedlinePlus related topics: Cancer Rashes Sun Exposure

Drug Information available for: Erlotinib hydrochloride Erlotinib ZD1839 Cetuximab Canertinib Canertinib dihydrochloride Panitumumab Matuzumab Zinc oxide

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Incidence and severity of rash development by Skindex questionnaire

Secondary Outcome Measures:

Toxicity by NCI CTCAE v3.0
Rash incidence at 4 and 8 weeks

Estimated Enrollment:	110
Study Start Date:	October 2006
Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Compare the incidence and severity of erlotinib-, cetuximab-, or other epidermal growth factor receptor inhibitor-induced skin rash development in patients with cancer treated with prophylactic topical sunscreen vs placebo.
Determine the toxicity of topical sunscreen vs placebo in these patients.
Determine whether discontinuation of treatment intervention is followed by rash development.

OUTLINE: This is a multicenter, randomized, double-blind, placebo-controlled study. Patients are stratified according to chemotherapy regimen (first-line chemotherapy vs other), epidermal growth factor receptor (EGFR) inhibitor therapy (small molecule vs monoclonal antibodies), concurrent medication that increases sun hypersensitivity (yes vs no), and gender. Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients apply sunscreen generously to the entire body twice daily for 4 weeks.
Arm I: Patients apply placebo generously to the entire body twice daily for 4 weeks.

Patients complete self-reported questionnaires regarding their rash status at baseline and then weekly for 8 weeks.

After completion of study treatment, patients are followed for 8 weeks.

PROJECTED ACCRUAL: A total of 110 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of cancer
Receiving ≥ 1 of the following epidermal growth factor receptor (EGFR) inhibitor treatments:
- Gefitinib
- Cetuximab
- Erlotinib
- Panitumumab
- ICR-62
- Matuzumab
- CI-1033
EGFR treatment must have begun within the past 3 days
No rash (of any etiology) at study entry

PATIENT CHARACTERISTICS:

Able to apply sunscreen on face, trunk, and extremities
Able to complete questionnaire(s)
No history of allergic reactions or severe intolerance to sunscreen or its derivatives
No history of skin problems likely to reoccur during treatment
Must avoid heavy sun exposure, especially during the hours of noon to 4 pm daily

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
No concurrent tanning bed usage
No other concurrent topical sunscreens

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00362986

Show 208 Study Locations

Sponsors and Collaborators

North Central Cancer Treatment Group

National Cancer Institute (NCI)

Investigators

Study Chair:	Aminah Jatoi, MD	Mayo Clinic
Investigator:	Abby R. Thrower, MD, PhD	Cedar Rapids Oncology Associates

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Jatoi A, Thrower A, Sloan JA, Flynn PJ, Wentworth-Hartung NL, Dakhil SR, Mattar BI, Nikcevich DA, Novotny P, Sekulic A, Loprinzi CL. Does Sunscreen Prevent Epidermal Growth Factor Receptor (EGFR) Inhibitor-Induced Rash? Results of a Placebo-Controlled Trial from the North Central Cancer Treatment Group (N05C4). Oncologist. 2010 Aug 26; [Epub ahead of print]

Atherton PJ, Burger KN, Loprinzi CL, Neben Wittich MA, Miller RC, Jatoi A, Sloan JA. Using the Skindex-16 and Common Terminology Criteria for Adverse Events to assess rash symptoms: results of a pooled-analysis (N0993). Support Care Cancer. 2011 Sep 16; [Epub ahead of print]

ClinicalTrials.gov Identifier:	NCT00362986 History of Changes
Other Study ID Numbers:	CDR0000492254, NCCTG-N05C4
Study First Received:	August 10, 2006
Last Updated:	September 20, 2011
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

dermatologic complications
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:

Exanthema
Skin Diseases
Sunscreening Agents
Zinc Oxide
Titanium dioxide
Gefitinib
Cetuximab
Erlotinib
Radiation-Protective Agents
Protective Agents

Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses
Photosensitizing Agents
Radiation-Sensitizing Agents
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012