A Phase I Study of PS-341 in Combination With Paclitaxel in Metastatic Solid Tumors
I. Determine the maximum tolerated dose of bortezomib when given in combination with
paclitaxel in patients with locally advanced or metastatic solid tumors.
OUTLINE: This is a multicenter, dose-escalation study of bortezomib.
Patients receive bortezomib IV on days 2 and 9 and paclitaxel IV over 1 hour on days 1 and
8. For the first course only, patients do not receive paclitaxel on day 1. Courses repeat
every 3 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of bortezomib until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2
of 6 patients experience dose-limiting toxicity or greater than 80% 20S proteasome
inhibition. Once the MTD is determined, an additional 6-9 patients are accrued and treated
at that dose.
Patients are followed at 21 days.
PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Dose-limiting toxicity (DLT) defined as Common Terminology Criteria (CTC) version 2.0 grade 3 or greater non-hematologic toxicity or grade 4 hematologic toxicity with the exception of asymptomatic neutropenia [ANC < 500]
Ohio State University
United States: Food and Drug Administration
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