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
N/A
18 Years
N/A
Not Enrolling
Both
Dermatologic Complications, Unspecified Adult Solid Tumor, Protocol Specific
Both
Dermatologic Complications, Unspecified Adult Solid Tumor, Protocol Specific
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]
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.
Inclusion 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
Type of Study:
Interventional
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
Authority:
United States: Federal Government
Study ID:
CDR0000492254
NCT ID:
NCT00362986
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
Name | Location |
|---|---|
| Mayo Clinic - Jacksonville | Jacksonville, Florida 32224 |
| Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
| CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
| CCOP - Wichita | Wichita, Kansas 67214-3882 |
| Hurley Medical Center | Flint, Michigan 48503 |
| CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
| CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
| CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
| CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
| CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
| Rush-Copley Cancer Care Center | Aurora, Illinois 60507 |
| Joliet Oncology-Hematology Associates, Limited - West | Joliet, Illinois 60435 |
| Carle Cancer Center at Carle Foundation Hospital | Urbana, Illinois 61801 |
| Saint Anthony Memorial Health Centers | Michigan City, Indiana 46360 |
| Cedar Rapids Oncology Associates | Cedar Rapids, Iowa 52403 |
| Mercy Medical Center - Sioux City | Sioux City, Iowa 51104 |
| Siouxland Hematology-Oncology Associates, LLP | Sioux City, Iowa 51101 |
| St. Luke's Regional Medical Center | Sioux City, Iowa 51104 |
| CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan 48106 |
| Saint Joseph Mercy Cancer Center | Ann Arbor, Michigan 48106-0995 |
| Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn, Michigan 48123-2500 |
| Genesys Hurley Cancer Institute | Flint, Michigan 48503 |
| Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods, Michigan 48236 |
| Foote Hospital | Jackson, Michigan 49201 |
| Sparrow Regional Cancer Center | Lansing, Michigan 48912-1811 |
| Seton Cancer Institute - Saginaw | Saginaw, Michigan 48601 |
| St. John Macomb Hospital | Warren, Michigan 48093 |
| Fairview Ridges Hospital | Burnsville, Minnesota 55337 |
| Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids, Minnesota 55433 |
| CCOP - Duluth | Duluth, Minnesota 55805 |
| Fairview Southdale Hospital | Edina, Minnesota 55435 |
| Mercy and Unity Cancer Center at Unity Hospital | Fridley, Minnesota 55432 |
| Hutchinson Area Health Care | Hutchinson, Minnesota 55350 |
| Meeker County Memorial Hospital | Lichfield, Minnesota 55355 |
| Minnesota Oncology Hematology, PA - Maplewood | Maplewood, Minnesota 55109 |
| HealthEast Cancer Care at St. John's Hospital | Maplewood, Minnesota 55109 |
| Hennepin County Medical Center - Minneapolis | Minneapolis, Minnesota 55415 |
| Regions Hospital Cancer Care Center | St. Paul, Minnesota 55101 |
| United Hospital | St. Paul, Minnesota 55102 |
| Ridgeview Medical Center | Waconia, Minnesota 55387 |
| Minnesota Oncology Hematology, PA - Woodbury | Woodbury, Minnesota 55125 |
| MeritCare Broadway | Fargo, North Dakota 58122 |
| CCOP - MeritCare Hospital | Fargo, North Dakota 58122 |
| Geisinger Medical Center | Danville, Pennsylvania 17822-0001 |
| 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 |
| Rapid City Regional Hospital | Rapid City, South Dakota 57709 |
| Methodist Medical Center of Illinois | Peoria, Illinois 61636 |
| Memorial Hospital of South Bend | South Bend, Indiana 46601 |
| CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
| CCOP - Columbus | Columbus, Ohio 43206 |
| Veterans Affairs Medical Center - Dayton | Dayton, Ohio 45428 |
| CCOP - Dayton | Kettering, Ohio 45429 |
| Hinsdale, Illinois 60521 | |
| CCOP - Northern Indiana CR Consortium | South Bend, Indiana 46601 |
| Saint Joseph Regional Medical Center | South Bend, Indiana 46617 |
| John Stoddard Cancer Center at Iowa Methodist Medical Center | Des Moines, Iowa 50309 |
| John Stoddard Cancer Center | Des Moines, Iowa 50309 |
| St. Vincent Mercy Medical Center | Toledo, Ohio 43608 |
| Sioux Valley Hospital and University of South Dakota Medical Center | Sioux Falls, South Dakota 57117-5134 |
| CCOP - Toledo Community Hospital | Toledo, Ohio 43623-3456 |
| Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita, Kansas 67214 |
| Medical University of Ohio Cancer Center | Toledo, Ohio 43614 |
| Toledo Hospital | Toledo, Ohio 43606 |
| St. Vincent Hospital Regional Cancer Center | Green Bay, Wisconsin 54307-3508 |
| St. Mary's - Duluth Clinic Cancer Center | Duluth, Minnesota 55805 |
| McCreery Cancer Center at Ottumwa Regional | Ottumwa, Iowa 52501 |
| Green Bay Oncology, Limited - Escanaba | Escanaba, Michigan 49431 |
| Dickinson County Healthcare System | Iron Mountain, Michigan 49801 |
| St. Mary's Hospital Medical Center - Green Bay | Green Bay, Wisconsin 54303 |
| Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center | Green Bay, Wisconsin 54301-3526 |
| Green Bay Oncology, Limited at St. Mary's Hospital | Green Bay, Wisconsin 54303 |
| Bay Area Cancer Care Center at Bay Area Medical Center | Marinette, Wisconsin 54143 |
| Green Bay Oncology, Limited - Oconto Falls | Oconto Falls, Wisconsin 54154 |
| Green Bay Oncology, Limited - Sturgeon Bay | Sturgeon Bay, Wisconsin 54235 |
| Southwest Medical Center | Liberal, Kansas 67901 |
| Northern Rockies Radiation Oncology Center | Billings, Montana 59101 |
| Hematology-Oncology Centers of the Northern Rockies - Billings | Billings, Montana 59101 |
| St. Peter's Hospital | Helena, Montana 59601 |
| Kalispell Regional Medical Center | Kalispell, Montana 59901 |
| Glacier Oncology, PLLC | Kalispell, Montana 59901 |
| Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula, Montana 59802 |
| Montana Cancer Specialists at Montana Cancer Center | Missoula, Montana 59802 |
| Community Medical Center | Missoula, Montana 59801 |
| Adena Regional Medical Center | Chillicothe, Ohio 54601 |
| Doctors Hospital at Ohio Health | Columbus, Ohio 43228 |
| Riverside Methodist Hospital Cancer Care | Columbus, Ohio 43214 |
| Grady Memorial Hospital | Delaware, Ohio 43015 |
| Fairfield Medical Center | Lancaster, Ohio 43130 |
| Strecker Cancer Center at Marietta Memorial Hospital | Marietta, Ohio 45750 |
| Licking Memorial Cancer Care Program at Licking Memorial Hospital | Newark, Ohio 43055 |
| Community Hospital of Springfield and Clark County | Springfield, Ohio 45505 |
| Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital | Westerville, Ohio 43081 |
| Genesis - Good Samaritan Hospital | Zanesville, Ohio 43701 |
| Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph | Saint Joseph, Michigan 49085 |
| Elkhart General Hospital | Elkhart, Indiana 46515 |
| Mount Carmel Health - West Hospital | Columbus, Ohio 43222 |
| Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest | Allentown, Pennsylvania 18105 |
| St. Joseph Medical Center | Bloomington, Illinois 61701 |
| Graham Hospital | Canton, Illinois 61520 |
| Memorial Hospital | Carthage, Illinois 62321 |
| Eureka Community Hospital | Eureka, Illinois 61530 |
| Galesburg Cottage Hospital | Galesburg, Illinois 61401 |
| Galesburg Clinic | Galesburg, Illinois 61401 |
| Mason District Hospital | Havana, Illinois 62644 |
| Hopedale Medical Complex | Hopedale, Illinois 61747 |
| Kewanee Hospital | Kewanee, Illinois 61443 |
| McDonough District Hospital | Macomb, Illinois 61455 |
| Trinity Medical Center - East | Moline, Illinois 61265 |
| BroMenn Regional Medical Center | Normal, Illinois 61761 |
| Community Cancer Center | Normal, Illinois 61761 |
| Community Hospital of Ottawa | Ottawa, Illinois 61350 |
| Oncology Hematology Associates of Central Illinois, PC - Ottawa | Ottawa, Illinois 61350 |
| Cancer Treatment Center at Pekin Hospital | Pekin, Illinois 61554 |
| Oncology Hematology Associates of Central Illinois, PC - Peoria | Peoria, Illinois 61615 |
| OSF St. Francis Medical Center | Peoria, Illinois 61637 |
| Proctor Hospital | Peoria, Illinois 61614 |
| Illinois Valley Community Hospital | Peru, Illinois 61354 |
| Perry Memorial Hospital | Princeton, Illinois 61356 |
| St. Margaret's Hospital | Spring Valley, Illinois 61362 |
| St. Francis Hospital and Health Centers - Beech Grove Campus | Beech Grove, Indiana 46107 |
| Howard Community Hospital at Howard Regional Health System | Kokomo, Indiana 46904 |
| Center for Cancer Therapy at LaPorte Hospital and Health Services | La Porte, Indiana 46350 |
| Reid Hospital & Health Care Services, Incorporated | Richmond, Indiana 47374 |
| Bettendorf, Iowa 52722 | |
| Mercy Capitol Hospital | Des Moines, Iowa 50307 |
| Medical Oncology and Hematology Associates at John Stoddard Cancer Center | Des Moines, Iowa 50309 |
| Medical Oncology and Hematology Associates at Mercy Cancer Center | Des Moines, Iowa 50314 |
| Mercy Cancer Center at Mercy Medical Center - Des Moines | Des Moines, Iowa 50314 |
| Medical Oncology and Hematology Associates - West Des Moines | West Des Moines, Iowa 50266 |
| Cancer Center of Kansas, PA - Dodge City | Dodge City, Kansas 67801 |
| Hickman Cancer Center at Bixby Medical Center | Adrian, Michigan 49221 |
| Community Cancer Center of Monroe | Monroe, Michigan 48162 |
| MeritCare Clinic - Bemidji | Bemidji, Minnesota 56601 |
| 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 |
| Fulton County Health Center | Wauseon, Ohio 43567 |
| Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia, Ohio 45385 |
| 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 |
| St. Joseph's Hospital | St Paul, Minnesota 55102 |
| Missouri Baptist Cancer Center | St. Louis, Missouri 63131 |
| Cancer Resource Center - Lincoln | Lincoln, Nebraska 68510 |
| McFarland Clinic, PC | Ames, Iowa 50010 |
| Cancer Center of Kansas, PA - Chanute | Chanute, Kansas 66720 |
| Cancer Center of Kansas, PA - El Dorado | El Dorado, Kansas 67042 |
| Cancer Center of Kansas, PA - Kingman | Kingman, Kansas 67068 |
| Cancer Center of Kansas, PA - Newton | Newton, Kansas 67114 |
| Cancer Center of Kansas, PA - Parsons | Parsons, Kansas 67357 |
| Cancer Center of Kansas, PA - Pratt | Pratt, Kansas 67124 |
| Cancer Center of Kansas, PA - Salina | Salina, Kansas 67401 |
| Cancer Center of Kansas, PA - Wellington | Wellington, Kansas 67152 |
| Cancer Center of Kansas, PA - Wichita | Wichita, Kansas 67214 |
| Associates in Womens Health, PA - North Review | Wichita, Kansas 67208 |
| 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 |
