A Phase I Study of [111In-DTPA-D-Phe]-Octreotide in Patients With Refractory Malignancies Expressing Somatostatin Receptors
OBJECTIVES: I. Determine the maximum tolerated dose (MTD), toxic effects, and the
preliminary antitumor activity of indium In 111 pentetreotide.
OUTLINE: This is a dose escalation study. Patients receive indium In III pentetreotide
(OctreoScan) IV on day 1. Imaging is conducted on days 3 and 6. Treatment continues weekly
for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of at least 3 patients receive escalating doses of OctreoScan until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2
of 3 patients experience dose limiting toxicities. Patients are followed every 3 months for
the first year, then every 6 months thereafter.
PROJECTED ACCRUAL: Up to 35 patients will be accrued for this study.
Primary Purpose: Treatment
John R. Murren, MD
United States: Federal Government
|Yale Comprehensive Cancer Center||New Haven, Connecticut 06520-8028|