A Phase I Surrogate Endpoint Trial of Human Recombinant Endostatin in Patients With Advanced Solid Tumors Amenable to Biopsy
I. Determine the optimal biologic dose of endostatin in patients with advanced solid tumors.
II. Determine the safety and tolerability of this regimen in these patients. III. Determine
the extent, frequency, and duration of tumor response in these patients on this regimen.
IV. Determine the pharmacokinetic profile and interpatient pharmacologic variability of this
regimen in these patients.
V. Determine the recommended phase II dose and schedule of this regimen.
OUTLINE: This is a dose escalation study.
Patients undergo a biopsy during prestudy and after the second course of treatment. Patients
receive endostatin IV daily for 4 weeks. Patients on dose level 1-6 receive endostatin over
20 minutes. Patients on dose level 7 receive endostatin over 40 minutes, with no treatment
on day 2 of the first course only. Treatment continues every 4 weeks in the absence of
disease progression or unacceptable toxicity. Cohorts of 3-6 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 toxicity.
Patients are followed for 1 month.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Roy S. Herbst, MD, PhD
M.D. Anderson Cancer Center
United States: Food and Drug Administration
|University of Texas - MD Anderson Cancer Center||Houston, Texas 77030-4009|