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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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)

Conditions
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Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Drug: tetracycline hydrochloride
* Other: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tetracycline<br>Patients receive oral tetracycline twice daily. 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. | Drug: tetracycline hydrochloride<br> <br> |
| Placebo Comparator: placebo<br>Patients receive oral placebo twice daily. 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. | Other: placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rash severity |  | Up to 8 weeks | 
| 1-month incidence and severity |  | Up to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life |  | Up to 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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unspecified adult solid tumor, protocol specific