Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
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]
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.
Status | Completed |
Enrollment | 116 |
Est. completion date | October 2009 |
Est. primary completion date | July 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
United States | Hickman Cancer Center at Bixby Medical Center | Adrian | Michigan |
United States | Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest | Allentown | Pennsylvania |
United States | McFarland Clinic, PC | Ames | Iowa |
United States | AnMed Cancer Center | Anderson | South Carolina |
United States | CCOP - Michigan Cancer Research Consortium | Ann Arbor | Michigan |
United States | Saint Joseph Mercy Cancer Center | Ann Arbor | Michigan |
United States | Rush-Copley Cancer Care Center | Aurora | Illinois |
United States | St. Francis Hospital and Health Centers - Beech Grove Campus | Beech Grove | Indiana |
United States | MeritCare Clinic - Bemidji | Bemidji | Minnesota |
United States | Billings Clinic - Downtown | Billings | Montana |
United States | CCOP - Montana Cancer Consortium | Billings | Montana |
United States | Hematology-Oncology Centers of the Northern Rockies - Billings | Billings | Montana |
United States | Northern Rockies Radiation Oncology Center | Billings | Montana |
United States | St. Vincent Healthcare Cancer Care Services | Billings | Montana |
United States | Bismarck Cancer Center | Bismarck | North Dakota |
United States | Medcenter One Hospital Cancer Care Center | Bismarck | North Dakota |
United States | Mid Dakota Clinic, PC | Bismarck | North Dakota |
United States | St. Alexius Medical Center Cancer Center | Bismarck | North Dakota |
United States | St. Joseph Medical Center | Bloomington | Illinois |
United States | Wood County Oncology Center | Bowling Green | Ohio |
United States | Bozeman Deaconess Cancer Center | Bozeman | Montana |
United States | Fairview Ridges Hospital | Burnsville | Minnesota |
United States | St. James Healthcare Cancer Care | Butte | Montana |
United States | Graham Hospital | Canton | Illinois |
United States | Memorial Hospital | Carthage | Illinois |
United States | Cedar Rapids Oncology Associates | Cedar Rapids | Iowa |
United States | Cancer Center of Kansas, PA - Chanute | Chanute | Kansas |
United States | Adena Regional Medical Center | Chillicothe | Ohio |
United States | CCOP - Columbus | Columbus | Ohio |
United States | Doctors Hospital at Ohio Health | Columbus | Ohio |
United States | Grant Medical Center Cancer Care | Columbus | Ohio |
United States | Mount Carmel Health - West Hospital | Columbus | Ohio |
United States | Riverside Methodist Hospital Cancer Care | Columbus | Ohio |
United States | Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids | Minnesota |
United States | Geisinger Medical Center | Danville | Pennsylvania |
United States | CCOP - Dayton | Dayton | Ohio |
United States | David L. Rike Cancer Center at Miami Valley Hospital | Dayton | Ohio |
United States | Good Samaritan Hospital | Dayton | Ohio |
United States | Grandview Hospital | Dayton | Ohio |
United States | Samaritan North Cancer Care Center | Dayton | Ohio |
United States | Veterans Affairs Medical Center - Dayton | Dayton | Ohio |
United States | Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn | Michigan |
United States | Grady Memorial Hospital | Delaware | Ohio |
United States | CCOP - Iowa Oncology Research Association | Des Moines | Iowa |
United States | John Stoddard Cancer Center | Des Moines | Iowa |
United States | John Stoddard Cancer Center at Iowa Methodist Medical Center | Des Moines | Iowa |
United States | Medical Oncology and Hematology Associates at John Stoddard Cancer Center | Des Moines | Iowa |
United States | Medical Oncology and Hematology Associates at Mercy Cancer Center | Des Moines | Iowa |
United States | Mercy Cancer Center at Mercy Medical Center - Des Moines | Des Moines | Iowa |
United States | Mercy Capitol Hospital | Des Moines | Iowa |
United States | Cancer Center of Kansas, PA - Dodge City | Dodge City | Kansas |
United States | CCOP - Duluth | Duluth | Minnesota |
United States | Miller-Dwan Medical Center | Duluth | Minnesota |
United States | St. Mary's - Duluth Clinic Cancer Center | Duluth | Minnesota |
United States | Fairview Southdale Hospital | Edina | Minnesota |
United States | St. Anthony's Memorial Hospital | Effingham | Illinois |
United States | Cancer Center of Kansas, PA - El Dorado | El Dorado | Kansas |
United States | Elkhart General Hospital | Elkhart | Indiana |
United States | Green Bay Oncology, Limited - Escanaba | Escanaba | Michigan |
United States | Eureka Community Hospital | Eureka | Illinois |
United States | CCOP - MeritCare Hospital | Fargo | North Dakota |
United States | MeritCare Broadway | Fargo | North Dakota |
United States | Blanchard Valley Medical Associates | Findlay | Ohio |
United States | Genesys Hurley Cancer Institute | Flint | Michigan |
United States | Hurley Medical Center | Flint | Michigan |
United States | Hematology-Oncology Associates of Fredericksburg, Incorporated | Fredericksburg | Virginia |
United States | Fremont Memorial Hospital | Fremont | Ohio |
United States | Mercy and Unity Cancer Center at Unity Hospital | Fridley | Minnesota |
United States | Galesburg Clinic | Galesburg | Illinois |
United States | Galesburg Cottage Hospital | Galesburg | Illinois |
United States | Great Falls Clinic - Main Facility | Great Falls | Montana |
United States | Green Bay Oncology, Limited at St. Mary's Hospital | Green Bay | Wisconsin |
United States | Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center | Green Bay | Wisconsin |
United States | St. Mary's Hospital Medical Center - Green Bay | Green Bay | Wisconsin |
United States | St. Vincent Hospital Regional Cancer Center | Green Bay | Wisconsin |
United States | Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods | Michigan |
United States | Mason District Hospital | Havana | Illinois |
United States | St. Peter's Hospital | Helena | Montana |
United States | Hopedale Medical Complex | Hopedale | Illinois |
United States | Hutchinson Area Health Care | Hutchinson | Minnesota |
United States | Dickinson County Healthcare System | Iron Mountain | Michigan |
United States | Foote Hospital | Jackson | Michigan |
United States | Mayo Clinic - Jacksonville | Jacksonville | Florida |
United States | Joliet Oncology-Hematology Associates, Limited - West | Joliet | Illinois |
United States | Glacier Oncology, PLLC | Kalispell | Montana |
United States | Kalispell Medical Oncology at KRMC | Kalispell | Montana |
United States | Kalispell Regional Medical Center | Kalispell | Montana |
United States | Charles F. Kettering Memorial Hospital | Kettering | Ohio |
United States | Kewanee Hospital | Kewanee | Illinois |
United States | Cancer Center of Kansas, PA - Kingman | Kingman | Kansas |
United States | Howard Community Hospital at Howard Regional Health System | Kokomo | Indiana |
United States | Center for Cancer Therapy at LaPorte Hospital and Health Services | La Porte | Indiana |
United States | Haematology-Oncology Associates of Ohio and Michigan, PC | Lambertville | Michigan |
United States | Fairfield Medical Center | Lancaster | Ohio |
United States | Sparrow Regional Cancer Center | Lansing | Michigan |
United States | Southwest Medical Center | Liberal | Kansas |
United States | Meeker County Memorial Hospital | Lichfield | Minnesota |
United States | Lima Memorial Hospital | Lima | Ohio |
United States | Cancer Resource Center - Lincoln | Lincoln | Nebraska |
United States | McDonough District Hospital | Macomb | Illinois |
United States | Immanuel St. Joseph's Clinic | Mankato | Minnesota |
United States | HealthEast Cancer Care at St. John's Hospital | Maplewood | Minnesota |
United States | Minnesota Oncology Hematology, PA - Maplewood | Maplewood | Minnesota |
United States | Strecker Cancer Center at Marietta Memorial Hospital | Marietta | Ohio |
United States | Bay Area Cancer Care Center at Bay Area Medical Center | Marinette | Wisconsin |
United States | Mercy Cancer Center at Mercy Medical Center - North Iowa | Mason City | Iowa |
United States | Northwest Ohio Oncology Center | Maumee | Ohio |
United States | St. Luke's Hospital | Maumee | Ohio |
United States | Saint Anthony Memorial Health Centers | Michigan City | Indiana |
United States | Middletown Regional Hospital | Middletown | Ohio |
United States | Hennepin County Medical Center - Minneapolis | Minneapolis | Minnesota |
United States | Virginia Piper Cancer Institute at Abbott-Northwestern Hospital | Minneapolis | Minnesota |
United States | Community Medical Center | Missoula | Montana |
United States | Guardian Oncology and Center for Wellness | Missoula | Montana |
United States | Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula | Montana |
United States | Montana Cancer Specialists at Montana Cancer Center | Missoula | Montana |
United States | Trinity Medical Center - East | Moline | Illinois |
United States | Community Cancer Center of Monroe | Monroe | Michigan |
United States | Mercy Memorial Hospital - Monroe | Monroe | Michigan |
United States | Licking Memorial Cancer Care Program at Licking Memorial Hospital | Newark | Ohio |
United States | Cancer Center of Kansas, PA - Newton | Newton | Kansas |
United States | BroMenn Regional Medical Center | Normal | Illinois |
United States | Community Cancer Center | Normal | Illinois |
United States | Green Bay Oncology, Limited - Oconto Falls | Oconto Falls | Wisconsin |
United States | Alegant Health Cancer Center at Bergan Mercy Medical Center | Omaha | Nebraska |
United States | CCOP - Missouri Valley Cancer Consortium | Omaha | Nebraska |
United States | Creighton University Medical Center | Omaha | Nebraska |
United States | Immanuel Medical Center | Omaha | Nebraska |
United States | St. Charles Mercy Hospital | Oregon | Ohio |
United States | Toledo Clinic - Oregon | Oregon | Ohio |
United States | Community Hospital of Ottawa | Ottawa | Illinois |
United States | Oncology Hematology Associates of Central Illinois, PC - Ottawa | Ottawa | Illinois |
United States | McCreery Cancer Center at Ottumwa Regional | Ottumwa | Iowa |
United States | Cancer Center of Kansas, PA - Parsons | Parsons | Kansas |
United States | Cancer Treatment Center at Pekin Hospital | Pekin | Illinois |
United States | CCOP - Illinois Oncology Research Association | Peoria | Illinois |
United States | Methodist Medical Center of Illinois | Peoria | Illinois |
United States | Oncology Hematology Associates of Central Illinois, PC - Peoria | Peoria | Illinois |
United States | OSF St. Francis Medical Center | Peoria | Illinois |
United States | Proctor Hospital | Peoria | Illinois |
United States | Illinois Valley Community Hospital | Peru | Illinois |
United States | Cancer Center of Kansas, PA - Pratt | Pratt | Kansas |
United States | Perry Memorial Hospital | Princeton | Illinois |
United States | Rapid City Regional Hospital | Rapid City | South Dakota |
United States | Reid Hospital & Health Care Services, Incorporated | Richmond | Indiana |
United States | Hubert H. Humphrey Cancer Center at North Memorial Medical Center | Robbinsdale | Minnesota |
United States | Mayo Clinic Cancer Center | Rochester | Minnesota |
United States | Rutherford Hospital | Rutherfordton | North Carolina |
United States | Seton Cancer Institute - Saginaw | Saginaw | Michigan |
United States | Arch Medical Services, Incorporated at Center for Cancer Care and Research | Saint Louis | Missouri |
United States | CCOP - Metro-Minnesota | Saint Louis Park | Minnesota |
United States | Cancer Center of Kansas, PA - Salina | Salina | Kansas |
United States | Firelands Regional Medical Center | Sandusky | Ohio |
United States | North Coast Cancer Care, Incorporated | Sandusky | Ohio |
United States | Saint Francis Cancer Center | Shakopee | Minnesota |
United States | Welch Cancer Center at Sheridan Memorial Hospital | Sheridan | Wyoming |
United States | Mercy Medical Center - Sioux City | Sioux City | Iowa |
United States | Siouxland Hematology-Oncology Associates, LLP | Sioux City | Iowa |
United States | St. Luke's Regional Medical Center | Sioux City | Iowa |
United States | Avera Cancer Institute | Sioux Falls | South Dakota |
United States | Medical X-Ray Center, PC | Sioux Falls | South Dakota |
United States | Sioux Valley Hospital and University of South Dakota Medical Center | Sioux Falls | South Dakota |
United States | CCOP - Northern Indiana CR Consortium | South Bend | Indiana |
United States | Memorial Hospital of South Bend | South Bend | Indiana |
United States | Saint Joseph Regional Medical Center | South Bend | Indiana |
United States | CCOP - Upstate Carolina | Spartanburg | South Carolina |
United States | Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg | South Carolina |
United States | St. Margaret's Hospital | Spring Valley | Illinois |
United States | Community Hospital of Springfield and Clark County | Springfield | Ohio |
United States | Mercy Medical Center | Springfield | Ohio |
United States | St. Joseph's Hospital | St Paul | Minnesota |
United States | Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph | St. Joseph | Michigan |
United States | Missouri Baptist Cancer Center | St. Louis | Missouri |
United States | Park Nicollet Health Services | St. Louis Park | Minnesota |
United States | Regions Hospital Cancer Care Center | St. Paul | Minnesota |
United States | United Hospital | St. Paul | Minnesota |
United States | Geisinger Medical Group - Scenery Park | State College | Pennsylvania |
United States | Green Bay Oncology, Limited - Sturgeon Bay | Sturgeon Bay | Wisconsin |
United States | Flower Hospital Cancer Center | Sylvania | Ohio |
United States | Mercy Hospital of Tiffin | Tiffin | Ohio |
United States | CCOP - Toledo Community Hospital | Toledo | Ohio |
United States | Medical University of Ohio Cancer Center | Toledo | Ohio |
United States | St. Vincent Mercy Medical Center | Toledo | Ohio |
United States | Toledo Clinic, Incorporated - Main Clinic | Toledo | Ohio |
United States | Toledo Hospital | Toledo | Ohio |
United States | UVMC Cancer Care Center at Upper Valley Medical Center | Troy | Ohio |
United States | Carle Cancer Center at Carle Foundation Hospital | Urbana | Illinois |
United States | CCOP - Carle Cancer Center | Urbana | Illinois |
United States | Ridgeview Medical Center | Waconia | Minnesota |
United States | St. John Macomb Hospital | Warren | Michigan |
United States | Fulton County Health Center | Wauseon | Ohio |
United States | Cancer Center of Kansas, PA - Wellington | Wellington | Kansas |
United States | Medical Oncology and Hematology Associates - West Des Moines | West Des Moines | Iowa |
United States | Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital | Westerville | Ohio |
United States | Associates in Womens Health, PA - North Review | Wichita | Kansas |
United States | Cancer Center of Kansas, PA - Medical Arts Tower | Wichita | Kansas |
United States | Cancer Center of Kansas, PA - Wichita | Wichita | Kansas |
United States | CCOP - Wichita | Wichita | Kansas |
United States | Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita | Kansas |
United States | Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center | Wilkes-Barre | Pennsylvania |
United States | Cancer Center of Kansas, PA - Winfield | Winfield | Kansas |
United States | Minnesota Oncology Hematology, PA - Woodbury | Woodbury | Minnesota |
United States | Woodwinds Health Campus | Woodbury | Minnesota |
United States | Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia | Ohio |
United States | Genesis - Good Samaritan Hospital | Zanesville | Ohio |
Lead Sponsor | Collaborator |
---|---|
Alliance for Clinical Trials in Oncology | National Cancer Institute (NCI) |
United States,
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. 2012 Aug;20(8):1729-35. doi: 10.1007/s00520-011-1266-x. — View Citation
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 tri — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence and severity of rash development by Skindex questionnaire | Up to 8 weeks | No | |
Secondary | Toxicity by NCI CTCAE v3.0 | Up to 8 weeks | Yes | |
Secondary | Rash incidence at 4 and 8 weeks | Up to 8 weeks | Yes |
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