Phase I Study Of Octreotide Acetate (Sandostatin) (SMS) As A Biomodulator Of Doxorubicin (DOX)
OBJECTIVES: I. Determine the toxicity and maximum tolerated dose of octreotide administered
with doxorubicin in patients with advanced cancer. II. Determine the pharmacokinetics and
pharmacodynamics of this treatment regimen in these patients.
OUTLINE: This is a dose escalation study of octreotide. Patients receive doxorubicin IV over
5 minutes on day 1 of course 1. For all subsequent courses, patients receive octreotide SC
continuously on days 1-7 and doxorubicin IV over 5 minutes on day 5. Treatment continues
every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients with
stable or responsive disease after 3 courses of therapy receive a maximum of 6 additional
courses. Cohorts of 3-6 patients receive escalating doses of octreotide 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.
PROJECTED ACCRUAL: Approximately 21-30 patients will be accrued for this study.
Primary Purpose: Treatment
G. S. Long, MD, PhD
University of Pittsburgh
United States: Federal Government
|University of Pittsburgh Cancer Institute||Pittsburgh, Pennsylvania 15213|