Pancreatic Cancer Clinical Trial
Official title:
Phase I Study Involving Gadolinium Texaphyrin (NSC 695238) in Patients With Pancreatic and Periampullary Adenocarcinoma Receiving Radiotherapy for Unresectable Disease
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as
gadolinium texaphyrin may make the tumor cells more sensitive to radiation therapy.
PURPOSE: Phase I trial to study the effectiveness of gadolinium texaphyrin plus radiation
therapy in treating patients who have cancer of the pancreas that cannot be removed by
surgery.
OBJECTIVES: I. Determine the maximum tolerated dose of gadolinium texaphyrin in patients
with locally advanced, unresectable pancreatic or periampullary adenocarcinoma undergoing
local regional radiotherapy. II. Determine the toxic effects of gadolinium texaphyrin with
concurrent radiotherapy in these patients. III. Correlate estimates of tumor and normal
organ gadolinium texaphyrin uptake and retention over time by MRI with plasma/serum levels
in these patients.
OUTLINE: This is a dose escalation study. Patients receive gadolinium texaphyrin IV over
5-10 minutes 4 times weekly at least 2 hours prior to external beam radiotherapy over 2.5
weeks (total of 10 fractions). Cohorts of 3-6 patients are treated at escalating doses of
gadolinium texaphyrin. The maximum tolerated dose is defined as the highest dose level in
which dose limiting toxicity occurs in no more than 2 of 6 patients. Patients are followed
once monthly for 2 months.
PROJECTED ACCRUAL: A total of 45 evaluable patients will be accrued for this study within
18-24 months.
;
Primary Purpose: Treatment
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