Unspecified Adult Solid Tumor, Protocol Specific
Conditions
Keywords
unspecified adult solid tumor, protocol specific
Brief summary
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
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.
Interventions
OTHERplacebo
Sponsors
National Cancer Institute (NCI)
Alliance for Clinical Trials in Oncology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rash severity | Up to 8 weeks |
| 1-month incidence and severity | Up to 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| quality of life | Up to 8 weeks |
Countries
United States
Outcome results
None listed