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Brief Title: Glufosfamide With or Without Hydration in Treating Patients With Advanced Pancreatic Cancer
Official Title: Open Label Phase II Study on Glufosfamide Administered as a 60 Minute Infusion Every 3 Weeks in Advanced Pancreatic Cancer
Study ID: NCT00005053
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Hydration with a saline solution may protect kidney cells from the side effects of chemotherapy. PURPOSE: Randomized phase II trial to compare the effectiveness of glufosfamide with or without hydration in treating patients who have pancreatic cancer that is metastatic or cannot be removed by surgery.
Detailed Description: 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 progression. PROJECTED ACCRUAL: A total of 16-32 patients (8-16 per arm) will be accrued for this study.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Herlev Hospital - University Hospital of Copenhagen, Herlev, , Denmark
Centre Leon Berard, Lyon, , France
CHU de la Timone, Marseille, , France
Centre Eugene Marquis, Rennes, , France
Centre Henri Becquerel, Rouen, , France
Universitats-Krankenhaus Eppendorf, Hamburg, , Germany
Medizinische Hochschule Hannover, Hannover, , Germany
Haemato-Onkologische Praxis und Tagesklinik, Munich, , Germany
Klinikum Nurnberg, Nuremberg, , Germany
University of Ioannina, Ioannina, , Greece
Rambam Medical Center, Haifa, , Israel
Academisch Ziekenhuis der Vrije Universiteit, Amsterdam, , Netherlands
Inselspital, Bern, Bern, , Switzerland
Centre Hospitalier Universitaire Vaudois, Lausanne, , Switzerland
Kantonsspital - Saint Gallen, Saint Gallen, , Switzerland
Name: Nicholas A. Pavlidis, MD
Affiliation: University of Ioannina
Role: STUDY_CHAIR