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

Sponsor
Alliance for Clinical Trials in Oncology (Other)
Overall Status
Completed
CT.gov ID
NCT00362986
Collaborator
National Cancer Institute (NCI) (NIH)
116
208
2
36
0.6
0

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
Phase 3

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
116 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
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]
Study Start Date :
Oct 1, 2006
Actual Primary Completion Date :
Jul 1, 2007
Actual Study Completion Date :
Oct 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: sunscreen

Patients apply sunscreen 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.

Drug: sunscreen

Placebo Comparator: placebo

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.

Other: placebo

Outcome Measures

Primary Outcome Measures

  1. Incidence and severity of rash development by Skindex questionnaire [Up to 8 weeks]

Secondary Outcome Measures

  1. Toxicity by NCI CTCAE v3.0 [Up to 8 weeks]

  2. Rash incidence at 4 and 8 weeks [Up to 8 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Mayo Clinic - Jacksonville Jacksonville Florida United States 32224
2 Rush-Copley Cancer Care Center Aurora Illinois United States 60507
3 St. Joseph Medical Center Bloomington Illinois United States 61701
4 Graham Hospital Canton Illinois United States 61520
5 Memorial Hospital Carthage Illinois United States 62321
6 St. Anthony's Memorial Hospital Effingham Illinois United States 62401
7 Eureka Community Hospital Eureka Illinois United States 61530
8 Galesburg Clinic Galesburg Illinois United States 61401
9 Galesburg Cottage Hospital Galesburg Illinois United States 61401
10 Mason District Hospital Havana Illinois United States 62644
11 Hopedale Medical Complex Hopedale Illinois United States 61747
12 Joliet Oncology-Hematology Associates, Limited - West Joliet Illinois United States 60435
13 Kewanee Hospital Kewanee Illinois United States 61443
14 McDonough District Hospital Macomb Illinois United States 61455
15 Trinity Medical Center - East Moline Illinois United States 61265
16 Moline Illinois United States 61265
17 BroMenn Regional Medical Center Normal Illinois United States 61761
18 Community Cancer Center Normal Illinois United States 61761
19 Community Hospital of Ottawa Ottawa Illinois United States 61350
20 Oncology Hematology Associates of Central Illinois, PC - Ottawa Ottawa Illinois United States 61350
21 Cancer Treatment Center at Pekin Hospital Pekin Illinois United States 61554
22 Proctor Hospital Peoria Illinois United States 61614
23 CCOP - Illinois Oncology Research Association Peoria Illinois United States 61615
24 Oncology Hematology Associates of Central Illinois, PC - Peoria Peoria Illinois United States 61615
25 Methodist Medical Center of Illinois Peoria Illinois United States 61636
26 OSF St. Francis Medical Center Peoria Illinois United States 61637
27 Illinois Valley Community Hospital Peru Illinois United States 61354
28 Perry Memorial Hospital Princeton Illinois United States 61356
29 St. Margaret's Hospital Spring Valley Illinois United States 61362
30 Carle Cancer Center at Carle Foundation Hospital Urbana Illinois United States 61801
31 CCOP - Carle Cancer Center Urbana Illinois United States 61801
32 St. Francis Hospital and Health Centers - Beech Grove Campus Beech Grove Indiana United States 46107
33 Elkhart General Hospital Elkhart Indiana United States 46515
34 Howard Community Hospital at Howard Regional Health System Kokomo Indiana United States 46904
35 Center for Cancer Therapy at LaPorte Hospital and Health Services La Porte Indiana United States 46350
36 Saint Anthony Memorial Health Centers Michigan City Indiana United States 46360
37 Reid Hospital & Health Care Services, Incorporated Richmond Indiana United States 47374
38 CCOP - Northern Indiana CR Consortium South Bend Indiana United States 46601
39 Memorial Hospital of South Bend South Bend Indiana United States 46601
40 Saint Joseph Regional Medical Center South Bend Indiana United States 46617
41 McFarland Clinic, PC Ames Iowa United States 50010
42 Bettendorf Iowa United States 52722
43 Cedar Rapids Oncology Associates Cedar Rapids Iowa United States 52403
44 Mercy Capitol Hospital Des Moines Iowa United States 50307
45 CCOP - Iowa Oncology Research Association Des Moines Iowa United States 50309
46 John Stoddard Cancer Center at Iowa Methodist Medical Center Des Moines Iowa United States 50309
47 Medical Oncology and Hematology Associates at John Stoddard Cancer Center Des Moines Iowa United States 50309
48 Medical Oncology and Hematology Associates at Mercy Cancer Center Des Moines Iowa United States 50314
49 Mercy Cancer Center at Mercy Medical Center - Des Moines Des Moines Iowa United States 50314
50 John Stoddard Cancer Center Des Moines Iowa United States 50316-2301
51 Mercy Cancer Center at Mercy Medical Center - North Iowa Mason City Iowa United States 50401
52 McCreery Cancer Center at Ottumwa Regional Ottumwa Iowa United States 52501
53 Siouxland Hematology-Oncology Associates, LLP Sioux City Iowa United States 51101
54 Mercy Medical Center - Sioux City Sioux City Iowa United States 51104
55 St. Luke's Regional Medical Center Sioux City Iowa United States 51104
56 Medical Oncology and Hematology Associates - West Des Moines West Des Moines Iowa United States 50266
57 Cancer Center of Kansas, PA - Chanute Chanute Kansas United States 66720
58 Cancer Center of Kansas, PA - Dodge City Dodge City Kansas United States 67801
59 Cancer Center of Kansas, PA - El Dorado El Dorado Kansas United States 67042
60 Cancer Center of Kansas, PA - Kingman Kingman Kansas United States 67068
61 Southwest Medical Center Liberal Kansas United States 67901
62 Cancer Center of Kansas, PA - Newton Newton Kansas United States 67114
63 Cancer Center of Kansas, PA - Parsons Parsons Kansas United States 67357
64 Cancer Center of Kansas, PA - Pratt Pratt Kansas United States 67124
65 Cancer Center of Kansas, PA - Salina Salina Kansas United States 67042
66 Cancer Center of Kansas, PA - Wellington Wellington Kansas United States 67152
67 Associates in Womens Health, PA - North Review Wichita Kansas United States 67203
68 Cancer Center of Kansas, PA - Medical Arts Tower Wichita Kansas United States 67208
69 Cancer Center of Kansas, PA - Wichita Wichita Kansas United States 67214
70 CCOP - Wichita Wichita Kansas United States 67214
71 Via Christi Cancer Center at Via Christi Regional Medical Center Wichita Kansas United States 67214
72 Cancer Center of Kansas, PA - Winfield Winfield Kansas United States 67156
73 Hickman Cancer Center at Bixby Medical Center Adrian Michigan United States 49221
74 Saint Joseph Mercy Cancer Center Ann Arbor Michigan United States 48106-0995
75 CCOP - Michigan Cancer Research Consortium Ann Arbor Michigan United States 48106
76 Oakwood Cancer Center at Oakwood Hospital and Medical Center Dearborn Michigan United States 48123-2500
77 Green Bay Oncology, Limited - Escanaba Escanaba Michigan United States 49431
78 Genesys Hurley Cancer Institute Flint Michigan United States 48503
79 Hurley Medical Center Flint Michigan United States 48503
80 Van Elslander Cancer Center at St. John Hospital and Medical Center Grosse Pointe Woods Michigan United States 48236
81 Dickinson County Healthcare System Iron Mountain Michigan United States 49801
82 Foote Hospital Jackson Michigan United States 49201
83 Haematology-Oncology Associates of Ohio and Michigan, PC Lambertville Michigan United States 48144
84 Sparrow Regional Cancer Center Lansing Michigan United States 48909
85 Community Cancer Center of Monroe Monroe Michigan United States 48162
86 Mercy Memorial Hospital - Monroe Monroe Michigan United States 48162
87 Seton Cancer Institute - Saginaw Saginaw Michigan United States 48601
88 Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph St. Joseph Michigan United States 49085
89 St. John Macomb Hospital Warren Michigan United States 48093
90 MeritCare Clinic - Bemidji Bemidji Minnesota United States 56601
91 Fairview Ridges Hospital Burnsville Minnesota United States 55337
92 Mercy and Unity Cancer Center at Mercy Hospital Coon Rapids Minnesota United States 55433
93 CCOP - Duluth Duluth Minnesota United States 55805
94 Miller-Dwan Medical Center Duluth Minnesota United States 55805
95 St. Mary's - Duluth Clinic Cancer Center Duluth Minnesota United States 55805
96 Fairview Southdale Hospital Edina Minnesota United States 55435
97 Mercy and Unity Cancer Center at Unity Hospital Fridley Minnesota United States 55432
98 Hutchinson Area Health Care Hutchinson Minnesota United States 55350
99 Meeker County Memorial Hospital Lichfield Minnesota United States 55355
100 Immanuel St. Joseph's Clinic Mankato Minnesota United States 56002
101 HealthEast Cancer Care at St. John's Hospital Maplewood Minnesota United States 55109
102 Minnesota Oncology Hematology, PA - Maplewood Maplewood Minnesota United States 55109
103 Virginia Piper Cancer Institute at Abbott-Northwestern Hospital Minneapolis Minnesota United States 55407
104 Hennepin County Medical Center - Minneapolis Minneapolis Minnesota United States 55415
105 Hubert H. Humphrey Cancer Center at North Memorial Medical Center Robbinsdale Minnesota United States 55422-2900
106 Mayo Clinic Cancer Center Rochester Minnesota United States 55905
107 CCOP - Metro-Minnesota Saint Louis Park Minnesota United States 55416
108 Saint Francis Cancer Center Shakopee Minnesota United States 55379
109 St. Joseph's Hospital St Paul Minnesota United States 55102
110 Park Nicollet Health Services St. Louis Park Minnesota United States 55416
111 Regions Hospital Cancer Care Center St. Paul Minnesota United States 55101
112 United Hospital St. Paul Minnesota United States 55102
113 Ridgeview Medical Center Waconia Minnesota United States 55387
114 Minnesota Oncology Hematology, PA - Woodbury Woodbury Minnesota United States 55125
115 Woodwinds Health Campus Woodbury Minnesota United States 55125
116 Arch Medical Services, Incorporated at Center for Cancer Care and Research Saint Louis Missouri United States 63141
117 Missouri Baptist Cancer Center St. Louis Missouri United States 63131
118 CCOP - Montana Cancer Consortium Billings Montana United States 59101
119 Hematology-Oncology Centers of the Northern Rockies - Billings Billings Montana United States 59101
120 Northern Rockies Radiation Oncology Center Billings Montana United States 59101
121 St. Vincent Healthcare Cancer Care Services Billings Montana United States 59101
122 Billings Clinic - Downtown Billings Montana United States 59107-7000
123 Bozeman Deaconess Cancer Center Bozeman Montana United States 59715
124 St. James Healthcare Cancer Care Butte Montana United States 59701
125 Great Falls Clinic - Main Facility Great Falls Montana United States 59405
126 Great Falls Montana United States 59405
127 St. Peter's Hospital Helena Montana United States 59601
128 Glacier Oncology, PLLC Kalispell Montana United States 59901
129 Kalispell Medical Oncology at KRMC Kalispell Montana United States 59901
130 Kalispell Regional Medical Center Kalispell Montana United States 59901
131 Community Medical Center Missoula Montana United States 59801
132 Guardian Oncology and Center for Wellness Missoula Montana United States 59804
133 Montana Cancer Specialists at Montana Cancer Center Missoula Montana United States 59807-7877
134 Montana Cancer Center at St. Patrick Hospital and Health Sciences Center Missoula Montana United States 59807
135 Cancer Resource Center - Lincoln Lincoln Nebraska United States 68510
136 CCOP - Missouri Valley Cancer Consortium Omaha Nebraska United States 68106
137 Immanuel Medical Center Omaha Nebraska United States 68122
138 Alegant Health Cancer Center at Bergan Mercy Medical Center Omaha Nebraska United States 68124
139 Creighton University Medical Center Omaha Nebraska United States 68131-2197
140 Rutherford Hospital Rutherfordton North Carolina United States 28139
141 Bismarck Cancer Center Bismarck North Dakota United States 58501
142 Medcenter One Hospital Cancer Care Center Bismarck North Dakota United States 58501
143 Mid Dakota Clinic, PC Bismarck North Dakota United States 58501
144 St. Alexius Medical Center Cancer Center Bismarck North Dakota United States 58502
145 CCOP - MeritCare Hospital Fargo North Dakota United States 58122
146 MeritCare Broadway Fargo North Dakota United States 58122
147 Wood County Oncology Center Bowling Green Ohio United States 43402
148 Adena Regional Medical Center Chillicothe Ohio United States 45601
149 Riverside Methodist Hospital Cancer Care Columbus Ohio United States 43214-3998
150 CCOP - Columbus Columbus Ohio United States 43215
151 Grant Medical Center Cancer Care Columbus Ohio United States 43215
152 Mount Carmel Health - West Hospital Columbus Ohio United States 43222
153 Doctors Hospital at Ohio Health Columbus Ohio United States 43228
154 Grandview Hospital Dayton Ohio United States 45405
155 Good Samaritan Hospital Dayton Ohio United States 45406
156 David L. Rike Cancer Center at Miami Valley Hospital Dayton Ohio United States 45409
157 Samaritan North Cancer Care Center Dayton Ohio United States 45415
158 Veterans Affairs Medical Center - Dayton Dayton Ohio United States 45428
159 CCOP - Dayton Dayton Ohio United States 45429
160 Grady Memorial Hospital Delaware Ohio United States 43015
161 Blanchard Valley Medical Associates Findlay Ohio United States 45840
162 Fremont Memorial Hospital Fremont Ohio United States 43420
163 Charles F. Kettering Memorial Hospital Kettering Ohio United States 45429
164 Fairfield Medical Center Lancaster Ohio United States 43130
165 Lima Memorial Hospital Lima Ohio United States 45804
166 Strecker Cancer Center at Marietta Memorial Hospital Marietta Ohio United States 45750
167 Northwest Ohio Oncology Center Maumee Ohio United States 43537
168 St. Luke's Hospital Maumee Ohio United States 43537
169 Middletown Regional Hospital Middletown Ohio United States 45044
170 Licking Memorial Cancer Care Program at Licking Memorial Hospital Newark Ohio United States 43055
171 St. Charles Mercy Hospital Oregon Ohio United States 43616
172 Toledo Clinic - Oregon Oregon Ohio United States 43616
173 Firelands Regional Medical Center Sandusky Ohio United States 44870
174 North Coast Cancer Care, Incorporated Sandusky Ohio United States 44870
175 Mercy Medical Center Springfield Ohio United States 45504
176 Community Hospital of Springfield and Clark County Springfield Ohio United States 45505
177 Flower Hospital Cancer Center Sylvania Ohio United States 43560
178 Mercy Hospital of Tiffin Tiffin Ohio United States 44883
179 Toledo Hospital Toledo Ohio United States 43606
180 St. Vincent Mercy Medical Center Toledo Ohio United States 43608
181 Medical University of Ohio Cancer Center Toledo Ohio United States 43614
182 CCOP - Toledo Community Hospital Toledo Ohio United States 43617
183 Toledo Clinic, Incorporated - Main Clinic Toledo Ohio United States 43623
184 UVMC Cancer Care Center at Upper Valley Medical Center Troy Ohio United States 45373-1300
185 Fulton County Health Center Wauseon Ohio United States 43567
186 Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital Westerville Ohio United States 43081
187 Ruth G. McMillan Cancer Center at Greene Memorial Hospital Xenia Ohio United States 45385
188 Genesis - Good Samaritan Hospital Zanesville Ohio United States 43701
189 Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest Allentown Pennsylvania United States 18105
190 Geisinger Medical Center Danville Pennsylvania United States 17822-0001
191 Geisinger Medical Group - Scenery Park State College Pennsylvania United States 16801
192 Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center Wilkes-Barre Pennsylvania United States 18711
193 AnMed Cancer Center Anderson South Carolina United States 29621
194 CCOP - Upstate Carolina Spartanburg South Carolina United States 29303
195 Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Spartanburg South Carolina United States 29303
196 Rapid City Regional Hospital Rapid City South Dakota United States 57701
197 Avera Cancer Institute Sioux Falls South Dakota United States 57105
198 Medical X-Ray Center, PC Sioux Falls South Dakota United States 57105
199 Sioux Valley Hospital and University of South Dakota Medical Center Sioux Falls South Dakota United States 57117-5039
200 Hematology-Oncology Associates of Fredericksburg, Incorporated Fredericksburg Virginia United States 22401
201 Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center Green Bay Wisconsin United States 54301-3526
202 Green Bay Oncology, Limited at St. Mary's Hospital Green Bay Wisconsin United States 54303
203 St. Mary's Hospital Medical Center - Green Bay Green Bay Wisconsin United States 54303
204 St. Vincent Hospital Regional Cancer Center Green Bay Wisconsin United States 54307-3508
205 Bay Area Cancer Care Center at Bay Area Medical Center Marinette Wisconsin United States 54143
206 Green Bay Oncology, Limited - Oconto Falls Oconto Falls Wisconsin United States 54154
207 Green Bay Oncology, Limited - Sturgeon Bay Sturgeon Bay Wisconsin United States 54235
208 Welch Cancer Center at Sheridan Memorial Hospital Sheridan Wyoming United States 82801

Sponsors and Collaborators

  • Alliance for Clinical Trials in Oncology
  • National Cancer Institute (NCI)

Investigators

  • Study Chair: Aminah Jatoi, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00362986
Other Study ID Numbers:
  • NCCTG-N05C4
  • NCI-2012-02700
  • CDR0000492254
First Posted:
Aug 15, 2006
Last Update Posted:
Dec 13, 2016
Last Verified:
Dec 1, 2016
Keywords provided by Alliance for Clinical Trials in Oncology
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 13, 2016