Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
A Phase I/II Study Of Imatinib Mesylate And Bevacizumab In Patients With Advanced Melanoma And Other Advanced Cancers
Phase II trial to study the effectiveness of combining imatinib mesylate with bevacizumab in treating patients who have advanced melanoma or other metastatic or unresectable cancer. Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Bevacizumab may stop the growth of tumor cells by stopping blood flow to the tumor. Combining imatinib mesylate with bevacizumab may kill more tumor cells
OBJECTIVES:
I. Determine the tolerability, maximum tolerated dose, and lowest biologically active dose of
imatinib mesylate and bevacizumab in patients with advanced melanoma or other advanced
cancers.
II. Determine the response rate, time to progression, and survival of patients treated with
this regimen.
III. Correlate clinical activity with inhibition of platelet-derived growth factor receptor
beta, vascular endothelial growth factor receptor, flt-1, and markers of angiogenesis in
patients treated with this regimen.
IV. Correlate clinical activity with alterations in tumor perfusion as assessed by dynamic
contrast-enhanced MRI and Doppler ultrasound in patients treated with this regimen.
V. Correlate toxicity, clinical activity, and correlative endpoints with the steady-stage
plasma concentration of imatinib mesylate in patients treated with this regimen.
OUTLINE: This is a dose-escalation, open-label study.
PHASE I (closed to accrual as of 8/23/04): Patients receive oral imatinib mesylate once or
twice daily on days 1-28 and bevacizumab IV over 30-90 minutes on days 1 and 14. Courses
repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of imatinib mesylate and bevacizumab 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.
PHASE II: Patients receive imatinib mesylate and bevacizumab as in phase I at the MTD.
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