Phase I Dose Escalation and Pharmacokinetics Study of the Radiosensitizer, Gadolinium Texaphyrin (Gd-Tex, NSC 695238) With Concurrent Radiotherapy in Advanced Biliary Tree and Pancreatic Cancers
OBJECTIVES: I. Determine the safety and toxicity of motexafin gadolinium (PCI-0120) when
administered concurrently with radiotherapy in patients with locally advanced unresectable
pancreatic or biliary tree tumors. II. Assess the pharmacokinetics of this regimen in these
patients. III. Assess tumor uptake of PCI-0120 (by MRI signal characteristics) in these
patients. IV. Determine the maximum tolerated dose of PCI-0120 in these patients. V.
Determine the objective response (by radiologic criteria) in patients treated with this
OUTLINE: This is a multicenter, dose-escalation study of motexafin gadolinium (PCI-0120).
Patients receive PCI-0120 IV over 15 minutes 3 times weekly concurrently with external beam
radiotherapy (EBRT) 5 days a week for 5.5 weeks. After completion of EBRT and PCI-0120,
patients may undergo radiotherapy boost for 5 consecutive days. Cohorts of 3-6 patients
receive escalating doses of PCI-0120 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. A total of 6-12 patients are treated at the recommended phase II
dose. The recommended phase II dose is defined as the dose immediately preceding the MTD.
Patients are followed at 4 weeks.
PROJECTED ACCRUAL: A total of 18-21 patients will be accrued for this study.
Primary Purpose: Treatment
Ramesh K. Ramanathan, MD
University of Pittsburgh
United States: Federal Government
|Norris Cotton Cancer Center||Lebanon, New Hampshire 03756|
|University of Pittsburgh Cancer Institute||Pittsburgh, Pennsylvania 15213|
|University of Wisconsin Comprehensive Cancer Center||Madison, Wisconsin 53792|