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