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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]

Phase 3
18 Years
Not Enrolling
Dermatologic Complications, Unspecified Adult Solid Tumor, Protocol Specific

Thank you

Trial Information

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]


- 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

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.

Inclusion Criteria


- Diagnosis of cancer

- Receiving ≥ 1 of the following epidermal growth factor receptor (EGFR) inhibitor

- 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


- 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

- 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


- See Disease Characteristics

- No concurrent tanning bed usage

- No other concurrent topical sunscreens

Type of Study:


Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care

Outcome Measure:

Incidence and severity of rash development by Skindex questionnaire

Principal Investigator

Aminah Jatoi, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

October 2006

Completion Date:

Related Keywords:

  • Dermatologic Complications
  • Unspecified Adult Solid Tumor, Protocol Specific
  • dermatologic complications
  • unspecified adult solid tumor, protocol specific
  • Exanthema



Mayo Clinic - Jacksonville Jacksonville, Florida  32224
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Rush-Copley Cancer Care Center Aurora, Illinois  60507
Joliet Oncology-Hematology Associates, Limited - West Joliet, Illinois  60435
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Saint Anthony Memorial Health Centers Michigan City, Indiana  46360
Cedar Rapids Oncology Associates Cedar Rapids, Iowa  52403
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Siouxland Hematology-Oncology Associates, LLP Sioux City, Iowa  51101
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Mercy and Unity Cancer Center at Mercy Hospital Coon Rapids, Minnesota  55433
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Mercy and Unity Cancer Center at Unity Hospital Fridley, Minnesota  55432
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Meeker County Memorial Hospital Lichfield, Minnesota  55355
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HealthEast Cancer Care at St. John's Hospital Maplewood, Minnesota  55109
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Geisinger Medical Group - Scenery Park State College, Pennsylvania  16801
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center Wilkes-Barre, Pennsylvania  18711
Medical X-Ray Center, PC Sioux Falls, South Dakota  57105
Avera Cancer Institute Sioux Falls, South Dakota  57105
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Eureka Community Hospital Eureka, Illinois  61530
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Hopedale Medical Complex Hopedale, Illinois  61747
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Trinity Medical Center - East Moline, Illinois  61265
BroMenn Regional Medical Center Normal, Illinois  61761
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Oncology Hematology Associates of Central Illinois, PC - Ottawa Ottawa, Illinois  61350
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Medical Oncology and Hematology Associates at John Stoddard Cancer Center Des Moines, Iowa  50309
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Community Cancer Center of Monroe Monroe, Michigan  48162
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Virginia Piper Cancer Institute at Abbott-Northwestern Hospital Minneapolis, Minnesota  55407
Hubert H. Humphrey Cancer Center at North Memorial Medical Center Robbinsdale, Minnesota  55422-2900
Park Nicollet Health Services St. Louis Park, Minnesota  55416
Immanuel Medical Center Omaha, Nebraska  68122
Creighton University Medical Center Omaha, Nebraska  68131-2197
Bismarck Cancer Center Bismarck, North Dakota  58501
Wood County Oncology Center Bowling Green, Ohio  43402
Samaritan North Cancer Care Center Dayton, Ohio  45415
Grandview Hospital Dayton, Ohio  45405
David L. Rike Cancer Center at Miami Valley Hospital Dayton, Ohio  45409
Good Samaritan Hospital Dayton, Ohio  45406
Blanchard Valley Medical Associates Findlay, Ohio  45840
Fremont Memorial Hospital Fremont, Ohio  43420
Charles F. Kettering Memorial Hospital Kettering, Ohio  45429
Lima Memorial Hospital Lima, Ohio  45804
St. Luke's Hospital Maumee, Ohio  43537
Northwest Ohio Oncology Center Maumee, Ohio  43537
Middletown Regional Hospital Middletown, Ohio  45044
Toledo Clinic - Oregon Oregon, Ohio  43616
St. Charles Mercy Hospital Oregon, Ohio  43616
North Coast Cancer Care, Incorporated Sandusky, Ohio  44870
Firelands Regional Medical Center Sandusky, Ohio  44870
Mercy Medical Center Springfield, Ohio  45504
Mercy Hospital of Tiffin Tiffin, Ohio  44883
Toledo Clinic, Incorporated - Main Clinic Toledo, Ohio  43623
UVMC Cancer Care Center at Upper Valley Medical Center Troy, Ohio  45373-1300
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Welch Cancer Center at Sheridan Memorial Hospital Sheridan, Wyoming  82801
St. Anthony's Memorial Hospital Effingham, Illinois  62401
Miller-Dwan Medical Center Duluth, Minnesota  55805
Mercy Cancer Center at Mercy Medical Center - North Iowa Mason City, Iowa  50401
Saint Francis Cancer Center Shakopee, Minnesota  55379
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Missouri Baptist Cancer Center St. Louis, Missouri  63131
Cancer Resource Center - Lincoln Lincoln, Nebraska  68510
McFarland Clinic, PC Ames, Iowa  50010
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Cancer Center of Kansas, PA - Newton Newton, Kansas  67114
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Cancer Center of Kansas, PA - Salina Salina, Kansas  67401
Cancer Center of Kansas, PA - Wellington Wellington, Kansas  67152
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Cancer Center of Kansas, PA - Medical Arts Tower Wichita, Kansas  67208
Cancer Center of Kansas, PA - Winfield Winfield, Kansas  67156
Haematology-Oncology Associates of Ohio and Michigan, PC Lambertville, Michigan  48144
Mercy Memorial Hospital - Monroe Monroe, Michigan  48162
Arch Medical Services, Incorporated at Center for Cancer Care and Research Saint Louis, Missouri  63141
Billings Clinic - Downtown Billings, Montana  59107-7000
Bozeman Deaconess Cancer Center Bozeman, Montana  59715
St. James Healthcare Cancer Care Butte, Montana  59701
Great Falls Clinic - Main Facility Great Falls, Montana  59405
Kalispell Medical Oncology at KRMC Kalispell, Montana  59901
Alegant Health Cancer Center at Bergan Mercy Medical Center Omaha, Nebraska  68124
Grant Medical Center Cancer Care Columbus, Ohio  43215
Flower Hospital Cancer Center Sylvania, Ohio  43560
Mid Dakota Clinic, PC Bismarck, North Dakota  58501
Immanuel St. Joseph's Clinic Mankato, Minnesota  56002
Rutherford Hospital Rutherfordton, North Carolina  28139
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Spartanburg, South Carolina  29303
Great Falls, Montana  59405
Guardian Oncology and Center for Wellness Missoula, Montana  59804
Woodwinds Health Campus Woodbury, Minnesota  55125
St. Vincent Healthcare Cancer Care Services Billings, Montana  59101
AnMed Cancer Center Anderson, South Carolina  29621
Medcenter One Hospital Cancer Care Center Bismarck, North Dakota  58501
St. Alexius Medical Center Cancer Center Bismarck, North Dakota  58502
Hematology-Oncology Associates of Fredericksburg, Incorporated Fredericksburg, Virginia  22401