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Spots Global Cancer Trial Database for Tetracycline in Preventing Skin Rash in Patients Who Are Receiving Drugs Such as Gefitinib and Cetuximab for Cancer

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Trial Identification

Brief Title: Tetracycline in Preventing Skin Rash in Patients Who Are Receiving Drugs Such as Gefitinib and Cetuximab for Cancer

Official Title: 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)

Study ID: NCT00091247

Study Description

Brief Summary: 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.

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Rush-Copley Cancer Care Center, Aurora, Illinois, United States

Joliet Oncology-Hematology Associates, Limited - West, Joliet, Illinois, United States

Carle Cancer Center at Carle Foundation Hospital, Urbana, Illinois, United States

CCOP - Carle Cancer Center, Urbana, Illinois, United States

Saint Anthony Memorial Health Centers, Michigan City, Indiana, United States

Cedar Rapids Oncology Associates, Cedar Rapids, Iowa, United States

Siouxland Hematology-Oncology Associates, LLP, Sioux City, Iowa, United States

Mercy Medical Center - Sioux City, Sioux City, Iowa, United States

St. Luke's Regional Medical Center, Sioux City, Iowa, United States

Cancer Center of Kansas, PA - Chanute, Chanute, Kansas, United States

Cancer Center of Kansas, PA - Dodge City, Dodge City, Kansas, United States

Cancer Center of Kansas, PA - El Dorado, El Dorado, Kansas, United States

Cancer Center of Kansas, PA - Kingman, Kingman, Kansas, United States

Southwest Medical Center, Liberal, Kansas, United States

Cancer Center of Kansas, PA - Newton, Newton, Kansas, United States

Cancer Center of Kansas, PA - Parsons, Parsons, Kansas, United States

Cancer Center of Kansas, PA - Pratt, Pratt, Kansas, United States

Cancer Center of Kansas, PA - Salina, Salina, Kansas, United States

Cancer Center of Kansas, PA - Wellington, Wellington, Kansas, 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

Cancer Center of Kansas, PA - Winfield, Winfield, Kansas, United States

Hickman Cancer Center at Bixby Medical Center, Adrian, Michigan, United States

Saint Joseph Mercy Cancer Center, Ann Arbor, Michigan, United States

CCOP - Michigan Cancer Research Consortium, Ann Arbor, Michigan, United States

Oakwood Cancer Center at Oakwood Hospital and Medical Center, Dearborn, Michigan, United States

Genesys Hurley Cancer Institute, Flint, Michigan, United States

Hurley Medical Center, Flint, Michigan, United States

Van Elslander Cancer Center at St. John Hospital and Medical Center, Grosse Pointe Woods, Michigan, United States

Foote Memorial Hospital, Jackson, Michigan, United States

Haematology-Oncology Associates of Ohio and Michigan, PC, Lambertville, Michigan, United States

Sparrow Regional Cancer Center, Lansing, Michigan, United States

St. Mary Mercy Hospital, Livonia, Michigan, United States

Community Cancer Center of Monroe, Monroe, Michigan, United States

Mercy Memorial Hospital - Monroe, Monroe, Michigan, United States

St. Joseph Mercy Oakland, Pontiac, Michigan, United States

Mercy Regional Cancer Center at Mercy Hospital, Port Huron, Michigan, United States

Seton Cancer Institute at Saint Mary's - Saginaw, Saginaw, Michigan, United States

St. John Macomb Hospital, Warren, Michigan, United States

MeritCare Bemidji, Bemidji, Minnesota, United States

Duluth Clinic Cancer Center - Duluth, Duluth, Minnesota, United States

CCOP - Duluth, Duluth, Minnesota, United States

Miller - Dwan Medical Center, Duluth, Minnesota, United States

Immanuel St. Joseph's, Mankato, Minnesota, United States

Mayo Clinic Cancer Center, Rochester, Minnesota, United States

CCOP - MeritCare Hospital, Fargo, North Dakota, United States

MeritCare Broadway, Fargo, North Dakota, United States

Wood County Oncology Center, Bowling Green, Ohio, United States

Hematology Oncology Center, Elyria, Ohio, United States

Lima Memorial Hospital, Lima, Ohio, United States

Northwest Ohio Oncology Center, Maumee, Ohio, United States

St. Luke's Hospital, Maumee, Ohio, United States

St. Charles Mercy Hospital, Oregon, Ohio, United States

Toledo Clinic - Oregon, Oregon, Ohio, United States

Firelands Regional Medical Center, Sandusky, Ohio, United States

North Coast Cancer Care, Incorporated, Sandusky, Ohio, United States

Flower Hospital Cancer Center, Sylvania, Ohio, United States

Mercy Hospital of Tiffin, Tiffin, Ohio, United States

Toledo Hospital, Toledo, Ohio, United States

St. Vincent Mercy Medical Center, Toledo, Ohio, United States

Medical University of Ohio Cancer Center, Toledo, Ohio, United States

CCOP - Toledo Community Hospital, Toledo, Ohio, United States

Toledo Clinic, Incorporated - Main Clinic, Toledo, Ohio, United States

Fulton County Health Center, Wauseon, Ohio, United States

Fredericksburg Oncology, Incorporated, Fredericksburg, Virginia, United States

Franciscan Skemp Healthcare - La Crosse Campus, La Crosse, Wisconsin, United States

Contact Details

Name: Aminah Jatoi, MD

Affiliation: Mayo Clinic

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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