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)”

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 Type: Interventional

Study Design: Supportive Care, Randomized, Double-Blind, Placebo Control

Study Primary Completion Date: February 2008

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.

Intervention(s) in this Clinical Trial

• Drug: tetracycline hydrochloride

Primary Measures

• Rash severity

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: North Central Cancer Treatment Group

Overall Clinical Trial Officials and Contacts

Aminah Jatoi, MD Study Chair Mayo Clinic  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00091247

Study ID Number: CDR0000385682

ClinicalTrials.gov Identifier: NCT00091247

Health Authority: United States: Federal Government

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