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

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	Drug: canertinib dihydrochloride Drug: cetuximab Drug: erlotinib hydrochloride Drug: gefitinib Drug: matuzumab Drug: panitumumab Drug: titanium dioxide/zinc oxide sunscreen cream SPF 60	Phase III

MedlinePlus related topics:

Cancer Rashes

ChemIDplus related topics:

Erlotinib Erlotinib hydrochloride ZD1839 Cetuximab Epidermal Growth Factor Panitumumab Canertinib Canertinib dihydrochloride Matuzumab Zinc oxide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Double-Blind, Placebo Control

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]

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

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 212 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

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

Study ID Numbers:	CDR0000492254, NCCTG-N05C4
First Received:	August 10, 2006
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00362986
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

dermatologic complications

unspecified adult solid tumor, protocol specific

Study placed in the following topic categories:

Erlotinib

Exanthema

Titanium dioxide

Skin Diseases

Cetuximab

Zinc

Gefitinib

Zinc Oxide

Additional relevant MeSH terms:

Radiation-Protective Agents

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Physiological Effects of Drugs

Enzyme Inhibitors

Protective Agents

Protein Kinase Inhibitors

Pharmacologic Actions

Photosensitizing Agents

Radiation-Sensitizing Agents

Therapeutic Uses

Sunscreening Agents

Dermatologic Agents

ClinicalTrials.gov processed this record on October 10, 2008

Sponsors and Collaborators:	North Central Cancer Treatment Group National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00362986