A Phase I Study of PS-341 in Combination With Paclitaxel in Metastatic Solid Tumors
PRIMARY OBJECTIVES:
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.
Interventional
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]
21 days
Yes
Charles Shapiro
Principal Investigator
Ohio State University
United States: Food and Drug Administration
NCI-2012-01408
NCT00030368
November 2001
Name | Location |
---|---|
Ohio State University Medical Center | Columbus, Ohio 43210 |