Phase I Study of Bortezomib and Gemcitabine in Elderly Patients With Solid Tumors (X05227)
- To determine the maximum tolerated dose of weekly bortezomib and gemcitabine in
treating elderly patients with advanced solid tumors.
- 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
- 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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose of bortezomib and gemcitabine
A minimum of a 3 week period (1 cycle) must be completed by all patients within a dose level before dose escalation to the next level may occur. A cycle is defined as treatment day 1 and 8 with follow-up through day 21.
Day 21 (Week 3 - Cycle 1)
Arkadiusz Dudek, MD
Masonic Cancer Center, University of Minnesota
United States: Food and Drug Administration
|Masonic Cancer Center at University of Minnesota||Minneapolis, Minnesota 55455|