Phase I of Trastuzumab and Imatinib Mesylate (Gleevec®, Formerly Known as STI-571) in Patients With Recurrent or Metastatic Her-2/Neu Expressing Cancer
- Determine the maximum tolerated dose of imatinib mesylate when administered with
trastuzumab (Herceptin®) in patients with recurrent or metastatic
- Determine response in patients treated with this regimen.
- Correlate the number of circulating tumor cells with radiographic imaging in patients
treated with this regimen.
OUTLINE: This is a dose-escalation study of imatinib mesylate.
Patients receive trastuzumab (Herceptin®) IV over 90 minutes on day 1 and oral imatinib
mesylate once or twice daily on days 1-21. Courses repeat every 21 days in the absence of
disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of imatinib mesylate 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.
PROJECTED ACCRUAL: Approximately 9-18 patients will be accrued for this study.
Primary Purpose: Treatment
Maximum tolerated dose (MTD) of imatinib mesylate given concurrently with trastuzumab (Herceptin®) as measured by CTC v 3.0 at course 1
Margaret von Mehren, MD
Fox Chase Cancer Center
United States: Federal Government
|Fox Chase Cancer Center||Philadelphia, Pennsylvania 19111|