Open Label Phase II Study on Glufosfamide Administered as a 60 Minute Infusion Every 3 Weeks in Advanced Pancreatic Cancer
OBJECTIVES: I. Determine the activity of glufosfamide as determined by objective response in
patients with metastatic or inoperable locally advanced pancreatic cancer. II. Determine the
response rate in this patient population after this treatment. III. Determine the duration
of objective response in these patients on this treatment. IV. Determine the toxic effects
of this regimen in these patients. V. Assess the impact of hydration on the toxicity profile
of this treatment in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two
treatment arms: Arm I: Patients receive glufosfamide IV over 1 hour on day 1. Arm II:
Patients receive glufosfamide as in arm I. Patients are hydrated with excess physiological
saline solution 4 hours before and for 3 hours after treatment with glufosfamide. Treatment
repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Patients with an objective complete response continue treatment for a maximum of 2 courses
beyond confirmation of response. Patients are followed every 6 weeks until disease
PROJECTED ACCRUAL: A total of 16-32 patients (8-16 per arm) will be accrued for this study.
Allocation: Randomized, Primary Purpose: Treatment
Nicholas A. Pavlidis, MD
University of Ioannina
United States: Federal Government