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

Condition(s) targeted: Unspecified Adult Solid Tumor, Protocol Specific

Intervention: tetracycline hydrochloride (Drug); placebo (Other)

Phase: N/A

Status: Completed

Sponsored by: Alliance for Clinical Trials in Oncology

Official(s) and/or principal investigator(s):
Aminah Jatoi, MD, Study Chair, Affiliation: Mayo Clinic

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.

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 design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Primary outcome:

Rash severity

1-month incidence and severity

Secondary outcome: quality of life

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

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

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

Clinical trial summary from the National Cancer Institute's PDQ® database

Related 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.

Starting date: December 2004
Last updated: July 7, 2015