Finding studies
Finding studies
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Lead
Masonic Cancer Center, University of Minnesota
OBJECTIVES: Primary * To determine the maximum tolerated dose of weekly bortezomib and gemcitabine in treating elderly patients with advanced solid tumors. Secondary * To characterize the quantitative and qualitative toxicities of bortezomib and gemcitabine in these patients. * To obtain preliminary information about the anti-tumor activity of bortezomib and gemcitabine. * To characterize gemcitabine and metabolite pharmacokinetics in patients receiving concurrent bortezomib therapy. OUTLINE: This is a phase I dose escalation study of bortezomib and gemcitabine. Patients receive gemcitabine intravenously (IV) over 30 minutes followed 1 hour later by bortezomib IV over 3-5 seconds on days 1 and 8. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of gemcitabine and bortezomib until the maximum tolerated dose of the combination is determined. Blood is collected periodically for pharmacokinetic and pharmacogenetic studies. After completion of study treatment, patients are followed every 3 months for up to 1 year.
Age
70–any
Sex
ALL
Healthy volunteers
Not accepted
