Glufosfamide With or Without Hydration in Treating Patients With Advanced Pancreatic Cancer
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.
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||Open Label Phase II Study on Glufosfamide Administered as a 60 Minute Infusion Every 3 Weeks in Advanced Pancreatic Cancer|
|Study Start Date:||December 1999|
|Primary Completion Date:||March 2001 (Final data collection date for primary outcome measure)|
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.
|Herlev Hospital - University Hospital of Copenhagen|
|Herlev, Denmark, DK-2730|
|Centre Leon Berard|
|Lyon, France, 69373|
|CHU de la Timone|
|Marseille, France, 13385|
|Centre Eugene Marquis|
|Rennes, France, 35064|
|Centre Henri Becquerel|
|Rouen, France, 76038|
|Hamburg, Germany, D-20246|
|Medizinische Hochschule Hannover|
|Hannover, Germany, D-30625|
|Haemato-Onkologische Praxis und Tagesklinik|
|Munich, Germany, D-80639|
|Nuremberg, Germany, D-90419|
|University of Ioannina|
|Ioannina, Greece, GR-45110|
|Rambam Medical Center|
|Haifa, Israel, 31096|
|Academisch Ziekenhuis der Vrije Universiteit|
|Amsterdam, Netherlands, 1117 MB|
|Bern, Switzerland, CH-3010|
|Centre Hospitalier Universitaire Vaudois|
|Lausanne, Switzerland, CH-1011|
|Kantonsspital - Saint Gallen|
|Saint Gallen, Switzerland, CH-9007|
|Study Chair:||Nicholas A. Pavlidis, MD||University of Ioannina|