Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Related Publications
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Objectives

1. 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.
2. Compare the toxicity of these drugs in these patients.
3. Compare the quality of life of patients treated with these drugs who develop vs those who do not develop a rash.
4. Determine whether patients who discontinue tetracycline at 1 month develop a rash.

Entry 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

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

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

Expected Enrollment

A total of 126 patients will be accrued for this study.

Outcomes

Rash severity

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.

Jatoi A, Dakhil SR, Sloan JA, et al.: 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 19 (10): 1601-7, 2011.[PUBMED Abstract]

Jatoi A, Rowland K, Sloan JA, et al.: 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 113 (4): 847-53, 2008.[PUBMED Abstract]

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.

Atherton PJ, Burger KN, Loprinzi CL, et al.: Using the Skindex-16 and Common Terminology Criteria for Adverse Events to assess rash symptoms: results of a pooled-analysis (N0993). Support Care Cancer : , 2011.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

Aminah Jatoi, MD, Protocol chair		Ph: 507-284-4918
Charles Loprinzi, MD, Protocol co-chair		Ph: 507-284-2511 Email: cloprinzi@mayo.edu

Registry Information
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)
Trial Start Date		2004-12-17
Trial Completion Date		2009-07-01
Registered in ClinicalTrials.gov		NCT00091247
Date Submitted to PDQ		2004-08-04
Information Last Verified		2009-07-01

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