An Exploratory, Placebo-Controlled Trial of Prophylactic Tetracycline for Gefitinib-or Cetuximab-Induced Skin Rash (or Other Epidermal Growth Factor Receptor (EGFR) Inhibitor-Induced Skin Rash)
18 Years
N/A
Both
Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
An Exploratory, Placebo-Controlled Trial of Prophylactic Tetracycline for Gefitinib-or Cetuximab-Induced Skin Rash (or Other Epidermal Growth Factor Receptor (EGFR) Inhibitor-Induced Skin Rash)
OBJECTIVES:
- 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 toxicity of these drugs in these patients.
- Compare the quality of life of patients treated with these drugs who develop vs those
who do not develop a rash.
- 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 I: Patients receive oral tetracycline twice daily.
- 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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of cancer
- Began therapy within the past 7 days or plans to begin therapy within 7 days after
study entry with one of the following epidermal growth factor receptor inhibitors:
- Gefitinib
- Cetuximab
- Erlotinib
- Monoclonal antibody ABX-EGF
- ICR-62
- CI-1033
- EMD-72000
- No rash at study entry
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Bilirubin ≤ 2 mg/dL
Renal
- Creatinine ≤ 2 mg/dL
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective non-hormonal contraception
- Able to take oral medication
- No history of skin condition that may flare during study treatment
- No prior allergic reaction or severe intolerance to tetracycline or one of its
derivatives
- No severe nausea or vomiting that would preclude retaining study drug
PRIOR CONCURRENT THERAPY:
Biologic therapy
- See Disease Characteristics
Chemotherapy
- Not specified
Endocrine therapy
- No concurrent oral contraceptives
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- More than 1 week since prior tetracycline
- No milk products, antacids, or calcium supplements for 2 hours before until 2 hours
after drug administration
- No other concurrent tetracycline
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
Outcome Measure:
Rash severity
Principal Investigator
Aminah Jatoi, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Mayo Clinic
Authority:
United States: Federal Government
Study ID:
CDR0000385682
NCT ID:
NCT00091247
Start Date:
December 2004
Completion Date:
Related Keywords:
- Unspecified Adult Solid Tumor, Protocol Specific
- unspecified adult solid tumor, protocol specific
- Exanthema
Name | Location |
|---|---|
| Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
| CCOP - Wichita | Wichita, Kansas 67214-3882 |
| Hurley Medical Center | Flint, Michigan 48503 |
| CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
| 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 |
| Sparrow Regional Cancer Center | Lansing, Michigan 48912-1811 |
| St. John Macomb Hospital | Warren, Michigan 48093 |
| MeritCare Bemidji | Bemidji, Minnesota 56601 |
| Duluth Clinic Cancer Center - Duluth | Duluth, Minnesota 55805-1983 |
| CCOP - Duluth | Duluth, Minnesota 55805 |
| Miller - Dwan Medical Center | Duluth, Minnesota 55805 |
| MeritCare Broadway | Fargo, North Dakota 58122 |
| CCOP - MeritCare Hospital | Fargo, North Dakota 58122 |
| St. Vincent Mercy Medical Center | Toledo, Ohio 43608 |
| 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 |
| Southwest Medical Center | Liberal, Kansas 67901 |
| 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 |
| Wood County Oncology Center | Bowling Green, Ohio 43402 |
| Lima Memorial Hospital | Lima, Ohio 45804 |
| St. Luke's Hospital | Maumee, Ohio 43537 |
| Northwest Ohio Oncology Center | Maumee, Ohio 43537 |
| 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 Hospital of Tiffin | Tiffin, Ohio 44883 |
| Toledo Clinic, Incorporated - Main Clinic | Toledo, Ohio 43623 |
| Fulton County Health Center | Wauseon, Ohio 43567 |
| 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 |
| Foote Memorial Hospital | Jackson, Michigan 49201 |
| Haematology-Oncology Associates of Ohio and Michigan, PC | Lambertville, Michigan 48144 |
| St. Mary Mercy Hospital | Livonia, Michigan 48154 |
| Mercy Memorial Hospital - Monroe | Monroe, Michigan 48162 |
| St. Joseph Mercy Oakland | Pontiac, Michigan 48341-2985 |
| Mercy Regional Cancer Center at Mercy Hospital | Port Huron, Michigan 48060 |
| Seton Cancer Institute at Saint Mary's - Saginaw | Saginaw, Michigan 48601 |
| Hematology Oncology Center | Elyria, Ohio 44035 |
| Flower Hospital Cancer Center | Sylvania, Ohio 43560 |
| Fredericksburg Oncology, Incorporated | Fredericksburg, Virginia 22401 |
| Franciscan Skemp Healthcare - La Crosse Campus | La Crosse, Wisconsin 54601 |
| Immanuel St. Joseph's | Mankato, Minnesota 56002 |
