Phase I Study of Endostatin in Advanced Cancer Patients
OBJECTIVES: I. Determine the maximum tolerated dose (MTD) and Phase II dose of endostatin in
patients with advanced refractory solid tumors. II. Determine the qualitative and
quantitative nature of the toxicities encountered with endostatin in this patient
population. III. Evaluate the basic pharmacokinetics and metabolism of endostatin by
measurement of plasma levels by EIA and mass spectrometry in this patient population. IV.
Investigate the relationship between pharmacokinetic parameters and toxicity in this patient
population. V. Evaluate biologic evidence of angiogenesis inhibition in patients receiving
OUTLINE: This is a dose escalation study. Patients receive endostatin IV over 1 hour daily
for 28 days, followed by 1 week of rest. Patients receive subsequent courses of daily
therapy in the absence of disease progression or unacceptable toxicity. Cohorts of 3
patients receive escalating doses of endostatin until the maximum tolerated dose (MTD) is
determined. The MTD is defined as the dose preceding that at which 2 of 6 patients
experience dose limiting toxicities.
PROJECTED ACCRUAL: Approximately 30-40 patients will be accrued for this study.
Primary Purpose: Treatment
James P. Thomas, MD, PhD
Ohio State University Comprehensive Cancer Center
United States: Federal Government
|University of Wisconsin Comprehensive Cancer Center||Madison, Wisconsin 53792|