- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00091247
Tetracycline in Preventing Skin Rash in Patients Who Are Receiving Drugs Such as Gefitinib and Cetuximab for Cancer
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)
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Illinois
-
Aurora, Illinois, United States, 60504
- Rush-Copley Cancer Care Center
-
Joliet, Illinois, United States, 60435
- Joliet Oncology-Hematology Associates, Limited - West
-
Urbana, Illinois, United States, 61801
- Carle Cancer Center at Carle Foundation Hospital
-
Urbana, Illinois, United States, 61801
- CCOP - Carle Cancer Center
-
-
Indiana
-
Michigan City, Indiana, United States, 46360
- Saint Anthony Memorial Health Centers
-
-
Iowa
-
Cedar Rapids, Iowa, United States, 52403
- Cedar Rapids Oncology Associates
-
Sioux City, Iowa, United States, 51101
- Siouxland Hematology-Oncology Associates, LLP
-
Sioux City, Iowa, United States, 51104
- St. Luke's Regional Medical Center
-
Sioux City, Iowa, United States, 51104
- Mercy Medical Center - Sioux City
-
-
Kansas
-
Chanute, Kansas, United States, 66720
- Cancer Center of Kansas, PA - Chanute
-
Dodge City, Kansas, United States, 67801
- Cancer Center of Kansas, PA - Dodge City
-
El Dorado, Kansas, United States, 67042
- Cancer Center of Kansas, PA - El Dorado
-
Kingman, Kansas, United States, 67068
- Cancer Center of Kansas, PA - Kingman
-
Liberal, Kansas, United States, 67901
- Southwest Medical Center
-
Newton, Kansas, United States, 67114
- Cancer Center of Kansas, PA - Newton
-
Parsons, Kansas, United States, 67357
- Cancer Center of Kansas, PA - Parsons
-
Pratt, Kansas, United States, 67124
- Cancer Center of Kansas, PA - Pratt
-
Salina, Kansas, United States, 67042
- Cancer Center of Kansas, PA - Salina
-
Wellington, Kansas, United States, 67152
- Cancer Center of Kansas, PA - Wellington
-
Wichita, Kansas, United States, 67208
- Cancer Center of Kansas, PA - Medical Arts Tower
-
Wichita, Kansas, United States, 67214
- Cancer Center of Kansas, PA - Wichita
-
Wichita, Kansas, United States, 67214
- CCOP - Wichita
-
Wichita, Kansas, United States, 67214
- Via Christi Cancer Center at Via Christi Regional Medical Center
-
Wichita, Kansas, United States, 67208
- Associates in Womens Health, PA - North Review
-
Winfield, Kansas, United States, 67156
- Cancer Center of Kansas, PA - Winfield
-
-
Michigan
-
Adrian, Michigan, United States, 49221
- Hickman Cancer Center at Bixby Medical Center
-
Ann Arbor, Michigan, United States, 48106-0995
- Saint Joseph Mercy Cancer Center
-
Ann Arbor, Michigan, United States, 48106
- CCOP - Michigan Cancer Research Consortium
-
Dearborn, Michigan, United States, 48123-2500
- Oakwood Cancer Center at Oakwood Hospital and Medical Center
-
Flint, Michigan, United States, 48503
- Hurley Medical Center
-
Flint, Michigan, United States, 48503
- Genesys Hurley Cancer Institute
-
Grosse Pointe Woods, Michigan, United States, 48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
-
Jackson, Michigan, United States, 49201
- Foote Memorial Hospital
-
Lambertville, Michigan, United States, 48144
- Haematology-Oncology Associates of Ohio and Michigan, PC
-
Lansing, Michigan, United States, 48912-1811
- Sparrow Regional Cancer Center
-
Livonia, Michigan, United States, 48154
- St. Mary Mercy Hospital
-
Monroe, Michigan, United States, 48162
- Community Cancer Center of Monroe
-
Monroe, Michigan, United States, 48162
- Mercy Memorial Hospital - Monroe
-
Pontiac, Michigan, United States, 48341-2985
- St. Joseph Mercy Oakland
-
Port Huron, Michigan, United States, 48060
- Mercy Regional Cancer Center at Mercy Hospital
-
Saginaw, Michigan, United States, 48601
- Seton Cancer Institute at Saint Mary's - Saginaw
-
Warren, Michigan, United States, 48093
- St. John Macomb Hospital
-
-
Minnesota
-
Bemidji, Minnesota, United States, 56601
- MeritCare Bemidji
-
Duluth, Minnesota, United States, 55805
- CCOP - Duluth
-
Duluth, Minnesota, United States, 55805-1983
- Duluth Clinic Cancer Center - Duluth
-
Duluth, Minnesota, United States, 55805
- Miller - Dwan Medical Center
-
Mankato, Minnesota, United States, 56002
- Immanuel St. Joseph's
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic Cancer Center
-
-
North Dakota
-
Fargo, North Dakota, United States, 58122
- CCOP - MeritCare Hospital
-
Fargo, North Dakota, United States, 58122
- MeritCare Broadway
-
-
Ohio
-
Bowling Green, Ohio, United States, 43402
- Wood County Oncology Center
-
Elyria, Ohio, United States, 44035
- Hematology Oncology Center
-
Lima, Ohio, United States, 45804
- Lima Memorial Hospital
-
Maumee, Ohio, United States, 43537
- Northwest Ohio Oncology Center
-
Maumee, Ohio, United States, 43537
- St. Luke's Hospital
-
Oregon, Ohio, United States, 43616
- St. Charles Mercy Hospital
-
Oregon, Ohio, United States, 43616
- Toledo Clinic - Oregon
-
Sandusky, Ohio, United States, 44870
- Firelands Regional Medical Center
-
Sandusky, Ohio, United States, 44870
- North Coast Cancer Care, Incorporated
-
Sylvania, Ohio, United States, 43560
- Flower Hospital Cancer Center
-
Tiffin, Ohio, United States, 44883
- Mercy Hospital of Tiffin
-
Toledo, Ohio, United States, 43608
- St. Vincent Mercy Medical Center
-
Toledo, Ohio, United States, 43606
- Toledo Hospital
-
Toledo, Ohio, United States, 43614
- Medical University of Ohio Cancer Center
-
Toledo, Ohio, United States, 43617
- CCOP - Toledo Community Hospital
-
Toledo, Ohio, United States, 43623
- Toledo Clinic, Incorporated - Main Clinic
-
Wauseon, Ohio, United States, 43567
- Fulton County Health Center
-
-
Virginia
-
Fredericksburg, Virginia, United States, 22401
- Fredericksburg Oncology, Incorporated
-
-
Wisconsin
-
La Crosse, Wisconsin, United States, 54601
- Franciscan Skemp Healthcare - La Crosse Campus
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
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:
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: tetracycline
Patients receive oral tetracycline twice daily. 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. |
|
PLACEBO_COMPARATOR: placebo
Patients receive oral placebo twice daily. 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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rash severity
Time Frame: Up to 8 weeks
|
Up to 8 weeks
|
1-month incidence and severity
Time Frame: Up to 8 weeks
|
Up to 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
quality of life
Time Frame: Up to 8 weeks
|
Up to 8 weeks
|
Collaborators and Investigators
Collaborators
Publications and helpful links
General Publications
- 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.
- Jatoi A, Dakhil SR, Sloan JA, Kugler JW, Rowland KM Jr, Schaefer PL, Novotny PJ, Wender DB, Gross HM, Loprinzi CL; North Central Cancer Treatment Group. Prophylactic tetracycline does not diminish the severity of epidermal growth factor receptor (EGFR) inhibitor-induced rash: results from the North Central Cancer Treatment Group (Supplementary N03CB). Support Care Cancer. 2011 Oct;19(10):1601-7. doi: 10.1007/s00520-010-0988-5. Epub 2010 Sep 6.
- Jatoi A, Rowland K, Sloan JA, Gross HM, Fishkin PA, Kahanic SP, Novotny PJ, Schaefer PL, Johnson DB, Tschetter LK, Loprinzi CL. Tetracycline to prevent epidermal growth factor receptor inhibitor-induced skin rashes: results of a placebo-controlled trial from the North Central Cancer Treatment Group (N03CB). Cancer. 2008 Aug 15;113(4):847-53. doi: 10.1002/cncr.23621.
- Jatoi A, Rowland K, Sloan JA, et al.: Does tetracycline prevent/palliate epidermal growth factor receptor (EGFR) inhibitor-induced rash? A phase III trial from the North Central Cancer Treatment Group (N03CB). [Abstract] J Clin Oncol 25 (Suppl 18): A-LBA9006, 494s, 2007.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCCTG-N03CB
- NCI-2011-01620 (REGISTRY: CTRP (Clinical Trials Reporting System))
- CDR0000385682 (REGISTRY: PDQ (Physician Data Query))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Unspecified Adult Solid Tumor, Protocol Specific
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)RecruitingCollection and Storage of Tissue Samples From Patients Undergoing Surgery For Suspected Solid TumorsUnspecified Childhood Solid Tumor, Protocol Specific | Unspecified Adult Solid Tumor, Protocol SpecificUnited States
-
Kantonsspital GraubuendenUnknownUnspecified Childhood Solid Tumor, Protocol Specific | Unspecified Adult Solid Tumor, Protocol SpecificSwitzerland
-
National Cancer Institute (NCI)CompletedUnspecified Childhood Solid Tumor, Protocol Specific | Unspecified Adult Solid Tumor, Protocol SpecificUnited States
-
Vanderbilt UniversityNational Cancer Institute (NCI)TerminatedUnspecified Childhood Solid Tumor, Protocol Specific | Unspecified Adult Solid Tumor, Protocol SpecificUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedUnspecified Childhood Solid Tumor, Protocol Specific | Unspecified Adult Solid Tumor, Protocol SpecificUnited States
-
University of ChicagoNational Cancer Institute (NCI)CompletedSirolimus in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed By SurgeryUnspecified Childhood Solid Tumor, Protocol Specific | Unspecified Adult Solid Tumor, Protocol SpecificUnited States
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)WithdrawnUnspecified Childhood Solid Tumor, Protocol Specific | Unspecified Adult Solid Tumor, Protocol Specific
-
Memorial Sloan Kettering Cancer CenterNational Cancer Institute (NCI)CompletedUnspecified Childhood Solid Tumor, Protocol Specific | Unspecified Adult Solid Tumor, Protocol SpecificUnited States
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI); Rutgers Cancer Institute of New JerseyWithdrawnUnspecified Childhood Solid Tumor, Protocol Specific | Unspecified Adult Solid Tumor, Protocol Specific | Hematopoietic/Lymphoid CancerUnited States
-
University of Texas Southwestern Medical CenterRecruitingUnspecified Adult Solid Tumor, Protocol SpecificUnited States
Clinical Trials on placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States