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.

Condition	Treatment or Intervention
unspecified adult solid tumor, protocol specific	Drug: tetracycline  Procedure: complications of therapy assessment/management  Procedure: dermatologic complications management  Procedure: supportive care/therapy

Further Study Details: 

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 66 patients (33 per treatment arm) will be accrued for this study within 12 months.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of cancer
• Began therapy with one of the following epidermal growth factor receptor inhibitors within the past week:
• 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

Minnesota
      Mayo Clinic Cancer Center, Rochester,  Minnesota,  55905,  United States; Recruiting

Study chairs or principal investigators

Aminah Jatoi, MD,  Study Chair,  Mayo Clinic Cancer Center   
Charles L. Loprinzi, MD,  Mayo Clinic Cancer Center   

Study ID Numbers:  CDR0000385682; NCCTG-N03CB; NCT00091247
Record last reviewed:  January 2005
Last Updated:  February 7, 2005
Record first received:  September 7, 2004
ClinicalTrials.gov Identifier:  NCT00091247
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08