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)

Phase: N/A

Status: Recruiting

Sponsored by: North Central Cancer Treatment Group

Official(s) and/or principal investigator(s):
Aminah Jatoi, MD, Study Chair, Affiliation: Mayo Clinic
Charles L. Loprinzi, MD, 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: Supportive Care, Randomized, Double-Blind, Placebo Control

Primary outcome: Rash severity

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

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

Carle Cancer Center at Carle Foundation Hospital, Urbana, Illinois 61801, United States; Recruiting
Clinical Trials Office - Carle Cancer Center, Phone: 800-446-5532

CCOP - Carle Cancer Center, Urbana, Illinois 61801, United States; Recruiting
Clinical Trials Office - CCOP - Carle Cancer Center, Phone: 800-446-5532

Joliet Oncology-Hematology Associates, Limited - West, Joliet, Illinois 60435, United States; Recruiting
Kendrith M. Rowland, MD, Phone: 217-383-3010

Rush-Copley Cancer Care Center, Aurora, Illinois 60504, United States; Recruiting
Kendrith M. Rowland, MD, Phone: 217-383-3010

Saint Anthony Memorial Health Centers, Michigan City, Indiana 46360, United States; Recruiting
Kendrith M. Rowland, MD, Phone: 217-383-3010

Cedar Rapids Oncology Associates, Cedar Rapids, Iowa 52403, United States; Recruiting
Clinical Trials Office - Cedar Rapids Oncology Associates, Phone: 319-363-2690

Mercy Medical Center - Sioux City, Sioux City, Iowa 51104, United States; Recruiting
Donald B. Wender, MD, PhD, Phone: 712-252-9326

Siouxland Hematology-Oncology Associates, LLP, Sioux City, Iowa 51101, United States; Recruiting
Donald B. Wender, MD, PhD, Phone: 712-252-9326

St. Luke's Regional Medical Center, Sioux City, Iowa 51104, United States; Recruiting
Donald B. Wender, MD, PhD, Phone: 712-252-9326

Associates in Womens Health, PA - North Review, Wichita, Kansas 67208, United States; Recruiting
Shaker R. Dakhil, MD, FACP, Phone: 316-262-4467

Cancer Center of Kansas, PA - Kingman, Kingman, Kansas 67068, United States; Recruiting
Shaker R. Dakhil, MD, FACP, Phone: 316-262-4467

Cancer Center of Kansas, PA - Wichita, Wichita, Kansas 67214, United States; Recruiting
Shaker R. Dakhil, MD, FACP, Phone: 316-262-4467

Cancer Center of Kansas, PA - Chanute, Chanute, Kansas 66720, United States; Recruiting
Shaker R. Dakhil, MD, FACP, Phone: 316-262-4467

Cancer Center of Kansas, PA - Dodge City, Dodge City, Kansas 67801, United States; Recruiting
Shaker R. Dakhil, MD, FACP, Phone: 316-262-4467

Cancer Center of Kansas, PA - El Dorado, El Dorado, Kansas 67042, United States; Recruiting
Shaker R. Dakhil, MD, FACP, Phone: 316-262-4467

Cancer Center of Kansas, PA - Medical Arts Tower, Wichita, Kansas 67208, United States; Recruiting
Shaker R. Dakhil, MD, FACP, Phone: 316-262-4467

Cancer Center of Kansas, PA - Newton, Newton, Kansas 67114, United States; Recruiting
Shaker R. Dakhil, MD, FACP, Phone: 316-262-4467

Cancer Center of Kansas, PA - Parsons, Parsons, Kansas 67357, United States; Recruiting
Shaker R. Dakhil, MD, FACP, Phone: 316-262-4467

Cancer Center of Kansas, PA - Pratt, Pratt, Kansas 67124, United States; Recruiting
Shaker R. Dakhil, MD, FACP, Phone: 316-262-4467

Cancer Center of Kansas, PA - Salina, Salina, Kansas 67042, United States; Recruiting
Shaker R. Dakhil, MD, FACP, Phone: 316-262-4467

Cancer Center of Kansas, PA - Wellington, Wellington, Kansas 67152, United States; Recruiting
Shaker R. Dakhil, MD, FACP, Phone: 316-262-4467

Cancer Center of Kansas, PA - Winfield, Winfield, Kansas 67156, United States; Recruiting
Shaker R. Dakhil, MD, FACP, Phone: 316-262-4467

CCOP - Wichita, Wichita, Kansas 67214, United States; Recruiting
Shaker R. Dakhil, MD, FACP, Phone: 316-262-4467

Southwest Medical Center, Liberal, Kansas 67901, United States; Recruiting
Shaker R. Dakhil, MD, FACP, Phone: 316-262-4467

Via Christi Cancer Center at Via Christi Regional Medical Center, Wichita, Kansas 67214, United States; Recruiting
Shaker R. Dakhil, MD, FACP, Phone: 316-262-4467

CCOP - Michigan Cancer Research Consortium, Ann Arbor, Michigan 48106, United States; Recruiting
Philip J. Stella, MD, Phone: 877-590-5995

Community Cancer Center of Monroe, Monroe, Michigan 48162, United States; Recruiting
Paul L. Schaefer, MD, Phone: 419-843-6147

Foote Memorial Hospital, Jackson, Michigan 49201, United States; Recruiting
Philip J. Stella, MD, Phone: 517-788-4800

Genesys Hurley Cancer Institute, Flint, Michigan 48503, United States; Recruiting
Clinical Trials Office - Genesys Hurley Cancer Institute, Phone: 810-762-8057

Haematology-Oncology Associates of Ohio and Michigan, PC, Lambertville, Michigan 48144, United States; Recruiting
Paul L. Schaefer, MD, Phone: 419-843-6147

Hickman Cancer Center at Bixby Medical Center, Adrian, Michigan 49221, United States; Recruiting
Clinical Trials Office - Hickman Cancer Center at Bixby Medica, Phone: 517-265-0116

Hurley Medical Center, Flint, Michigan 48503, United States; Recruiting
Clinical Trials Office - Hurley Medical Center, Phone: 810-762-8057

Mercy Memorial Hospital - Monroe, Monroe, Michigan 48162, United States; Recruiting
Paul L. Schaefer, MD, Phone: 419-843-6147

Mercy Regional Cancer Center at Mercy Hospital, Port Huron, Michigan 48060, United States; Recruiting
Philip J. Stella, MD, Phone: 810-985-1484

Oakwood Cancer Center at Oakwood Hospital and Medical Center, Dearborn, Michigan 48123-2500, United States; Recruiting
Clinical Trials Office - Oakwood Cancer Center at Oakwood Hosp, Phone: 313-593-8090

Saint Joseph Mercy Cancer Center, Ann Arbor, Michigan 48106-0995, United States; Recruiting
Philip J. Stella, MD, Phone: 734-712-5658

Seton Cancer Institute at Saint Mary's - Saginaw, Saginaw, Michigan 48601, United States; Recruiting
Clinical Trials Office - Seton Cancer Institute - Saginaw, Phone: 989-776-8411

Sparrow Regional Cancer Center, Lansing, Michigan 48912-1811, United States; Recruiting
Clinical Trials Office - Sparrow Regional Cancer Center, Phone: 517-364-2890

St. John Macomb Hospital, Warren, Michigan 48093, United States; Recruiting
Philip J. Stella, MD, Phone: 586-573-5757

St. Joseph Mercy Oakland, Pontiac, Michigan 48341-2985, United States; Recruiting
Philip J. Stella, MD, Phone: 248-858-3612

St. Mary Mercy Hospital, Livonia, Michigan 48154, United States; Recruiting
Philip J. Stella, MD, Phone: 734-464-4800

Van Elslander Cancer Center at St. John Hospital and Medical Center, Grosse Pointe Woods, Michigan 48236, United States; Recruiting
Clincial Trials Office - Van Elslander Cancer Center at St. Jo, Phone: 313-343-3166

CCOP - Duluth, Duluth, Minnesota 55805, United States; Recruiting
Daniel Nikcevich, MD, PhD, Phone: 218-786-8364

Duluth Clinic Cancer Center - Duluth, Duluth, Minnesota 55805-1983, United States; Recruiting
Clinical Trials Office - Duluth Clinic Cancer Center - Duluth, Phone: 218-786-3308

Immanuel St. Joseph's, Mankato, Minnesota 56002, United States; Recruiting
Glenn S. Harman, MD, Phone: 507-625-4031

Mayo Clinic Cancer Center, Rochester, Minnesota 55905, United States; Recruiting
Clinical Trials Office - All Mayo Clinic Locations, Phone: 507-538-7623

MeritCare Bemidji, Bemidji, Minnesota 56601, United States; Recruiting
Preston D. Steen, MD, Phone: 701-234-2397

Miller - Dwan Medical Center, Duluth, Minnesota 55805, United States; Recruiting
Daniel Nikcevich, MD, PhD, Phone: 218-727-8762

CCOP - MeritCare Hospital, Fargo, North Dakota 58122, United States; Recruiting
Preston D. Steen, MD, Phone: 701-234-2397

MeritCare Broadway, Fargo, North Dakota 58122, United States; Recruiting
Preston D. Steen, MD, Phone: 701-234-2397

CCOP - Toledo Community Hospital, Toledo, Ohio 43617, United States; Recruiting
Paul L. Schaefer, MD, Phone: 419-843-6147

Firelands Regional Medical Center, Sandusky, Ohio 44870, United States; Recruiting
Paul L. Schaefer, MD, Phone: 419-843-6147

Flower Hospital Cancer Center, Sylvania, Ohio 43560, United States; Recruiting
Clinical Trials Office - Flower Hospital Cancer Center, Phone: 419-824-1842

Fulton County Health Center, Wauseon, Ohio 43567, United States; Recruiting
Clinical Trials Office - Fulton County Health Center, Phone: 419-330-2708

Hematology Oncology Center, Elyria, Ohio 44035, United States; Recruiting
Paul L. Schaefer, MD, Phone: 419-843-6147

Lima Memorial Hospital, Lima, Ohio 45804, United States; Recruiting
Paul L. Schaefer, MD, Phone: 419-843-6147

Medical University of Ohio Cancer Center, Toledo, Ohio 43614, United States; Recruiting
Clinical Trials Office - Medical University of Ohio Cancer Cen, Phone: 419-383-6583

Mercy Hospital of Tiffin, Tiffin, Ohio 44883, United States; Recruiting
Paul L. Schaefer, MD, Phone: 419-843-6147

North Coast Cancer Care, Incorporated, Sandusky, Ohio 44870, United States; Recruiting
Paul L. Schaefer, MD, Phone: 419-843-6147

Northwest Ohio Oncology Center, Maumee, Ohio 43537, United States; Recruiting
Paul L. Schaefer, MD, Phone: 419-843-6147

St. Charles Mercy Hospital, Oregon, Ohio 43616, United States; Recruiting
Paul L. Schaefer, MD, Phone: 419-843-6147

St. Luke's Hospital, Maumee, Ohio 43537, United States; Recruiting
Paul L. Schaefer, MD, Phone: 419-843-6147

St. Vincent Mercy Medical Center, Toledo, Ohio 43608, United States; Recruiting
Paul L. Schaefer, MD, Phone: 419-843-6147

Toledo Clinic - Oregon, Oregon, Ohio 43616, United States; Recruiting
Paul L. Schaefer, MD, Phone: 419-843-6147

Toledo Clinic, Incorporated - Main Clinic, Toledo, Ohio 43623, United States; Recruiting
Paul L. Schaefer, MD, Phone: 419-843-6147

Toledo Hospital, Toledo, Ohio 43606, United States; Recruiting
Clinical Trials Office - Toledo Hospital, Phone: 419-824-1842

Wood County Oncology Center, Bowling Green, Ohio 43402, United States; Recruiting
Paul L. Schaefer, MD, Phone: 419-843-6147

Fredericksburg Oncology, Incorporated, Fredericksburg, Virginia 22401, United States; Recruiting
Paul L. Schaefer, MD, Phone: 419-843-6147

Franciscan Skemp Healthcare - La Crosse Campus, La Crosse, Wisconsin 54601, United States; Recruiting
Paula Gill, Phone: 608-785-0940

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

Starting date: December 2004
Last updated: October 8, 2008