RATIONALE: Tetracycline may be effective in preventing skin rash that is caused by treatment
with drugs such as gefitinib or cetuximab.
PURPOSE: This randomized clinical trial is studying tetracycline to see how well it works
compared to placebo in preventing skin rash in patients who are receiving drugs such as
gefitinib or cetuximab for cancer.
- Compare the 1-month incidence and severity of gefitinib-, cetuximab-, or other
epidermal growth factor receptor inhibitor-induced skin rash development in patients
with cancer treated with tetracycline vs placebo.
- Compare the quality of life of patients treated with these drugs who develop vs those
- Determine whether patients who discontinue tetracycline at 1 month develop a rash.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
are stratified according to prior chemotherapy regimen (first-line therapy vs other),
concurrent epidermal growth factor receptor inhibitor therapy (gefitinib vs cetuximab vs
other), and concurrent corticosteroid therapy (yes vs no). Patients are randomized to 1 of 2
treatment arms.
- Arm II: Patients receive oral placebo twice daily. In both arms, treatment continues
for 4 weeks in the absence of unacceptable toxicity.
Quality of life is assessed at baseline and then weekly for 8 weeks.
Patients are followed at weeks 4 and 8.
PROJECTED ACCRUAL: A total of 126 patients will be accrued for this study.
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Rush-Copley Cancer Care Center, Aurora, Illinois 60504, United States
Joliet Oncology-Hematology Associates, Limited - West, Joliet, Illinois 60435, United States
Carle Cancer Center at Carle Foundation Hospital, Urbana, Illinois 61801, United States
CCOP - Carle Cancer Center, Urbana, Illinois 61801, United States
Saint Anthony Memorial Health Centers, Michigan City, Indiana 46360, United States
Cedar Rapids Oncology Associates, Cedar Rapids, Iowa 52403, United States
Mercy Medical Center - Sioux City, Sioux City, Iowa 51104, United States
Siouxland Hematology-Oncology Associates, LLP, Sioux City, Iowa 51101, United States
St. Luke's Regional Medical Center, Sioux City, Iowa 51104, United States
Cancer Center of Kansas, PA - Chanute, Chanute, Kansas 66720, United States
Cancer Center of Kansas, PA - Dodge City, Dodge City, Kansas 67801, United States
Cancer Center of Kansas, PA - El Dorado, El Dorado, Kansas 67042, United States
Cancer Center of Kansas, PA - Kingman, Kingman, Kansas 67068, United States
Southwest Medical Center, Liberal, Kansas 67901, United States
Cancer Center of Kansas, PA - Newton, Newton, Kansas 67114, United States
Cancer Center of Kansas, PA - Parsons, Parsons, Kansas 67357, United States
Cancer Center of Kansas, PA - Pratt, Pratt, Kansas 67124, United States
Cancer Center of Kansas, PA - Salina, Salina, Kansas 67042, United States
Cancer Center of Kansas, PA - Wellington, Wellington, Kansas 67152, United States
Associates in Womens Health, PA - North Review, Wichita, Kansas 67208, United States
Cancer Center of Kansas, PA - Medical Arts Tower, Wichita, Kansas 67208, United States
Cancer Center of Kansas, PA - Wichita, Wichita, Kansas 67214, United States
CCOP - Wichita, Wichita, Kansas 67214, United States
Via Christi Cancer Center at Via Christi Regional Medical Center, Wichita, Kansas 67214, United States
Cancer Center of Kansas, PA - Winfield, Winfield, Kansas 67156, United States
Hickman Cancer Center at Bixby Medical Center, Adrian, Michigan 49221, United States
CCOP - Michigan Cancer Research Consortium, Ann Arbor, Michigan 48106, United States
Saint Joseph Mercy Cancer Center, Ann Arbor, Michigan 48106-0995, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center, Dearborn, Michigan 48123-2500, United States
Genesys Hurley Cancer Institute, Flint, Michigan 48503, United States
Hurley Medical Center, Flint, Michigan 48503, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center, Grosse Pointe Woods, Michigan 48236, United States
Foote Memorial Hospital, Jackson, Michigan 49201, United States
Haematology-Oncology Associates of Ohio and Michigan, PC, Lambertville, Michigan 48144, United States
Sparrow Regional Cancer Center, Lansing, Michigan 48912-1811, United States
St. Mary Mercy Hospital, Livonia, Michigan 48154, United States
Community Cancer Center of Monroe, Monroe, Michigan 48162, United States
Mercy Memorial Hospital - Monroe, Monroe, Michigan 48162, United States
St. Joseph Mercy Oakland, Pontiac, Michigan 48341-2985, United States
Mercy Regional Cancer Center at Mercy Hospital, Port Huron, Michigan 48060, United States
Seton Cancer Institute at Saint Mary's - Saginaw, Saginaw, Michigan 48601, United States
St. John Macomb Hospital, Warren, Michigan 48093, United States
MeritCare Bemidji, Bemidji, Minnesota 56601, United States
CCOP - Duluth, Duluth, Minnesota 55805, United States
Duluth Clinic Cancer Center - Duluth, Duluth, Minnesota 55805-1983, United States
Miller - Dwan Medical Center, Duluth, Minnesota 55805, United States
Immanuel St. Joseph's, Mankato, Minnesota 56002, United States
Mayo Clinic Cancer Center, Rochester, Minnesota 55905, United States
CCOP - MeritCare Hospital, Fargo, North Dakota 58122, United States
MeritCare Broadway, Fargo, North Dakota 58122, United States
Wood County Oncology Center, Bowling Green, Ohio 43402, United States
Hematology Oncology Center, Elyria, Ohio 44035, United States
Lima Memorial Hospital, Lima, Ohio 45804, United States
Northwest Ohio Oncology Center, Maumee, Ohio 43537, United States
St. Luke's Hospital, Maumee, Ohio 43537, United States
St. Charles Mercy Hospital, Oregon, Ohio 43616, United States
Toledo Clinic - Oregon, Oregon, Ohio 43616, United States
Firelands Regional Medical Center, Sandusky, Ohio 44870, United States
North Coast Cancer Care, Incorporated, Sandusky, Ohio 44870, United States
Flower Hospital Cancer Center, Sylvania, Ohio 43560, United States
Mercy Hospital of Tiffin, Tiffin, Ohio 44883, United States
CCOP - Toledo Community Hospital, Toledo, Ohio 43617, United States
Medical University of Ohio Cancer Center, Toledo, Ohio 43614, United States
St. Vincent Mercy Medical Center, Toledo, Ohio 43608, United States
Toledo Clinic, Incorporated - Main Clinic, Toledo, Ohio 43623, United States
Toledo Hospital, Toledo, Ohio 43606, United States
Fulton County Health Center, Wauseon, Ohio 43567, United States
Fredericksburg Oncology, Incorporated, Fredericksburg, Virginia 22401, United States
Franciscan Skemp Healthcare - La Crosse Campus, La Crosse, Wisconsin 54601, 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. Epub 2011 Sep 16.