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

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.

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