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.

Condition	Treatment or Intervention	Phase
recurrent pancreatic cancer stage IVA pancreatic cancer stage III pancreatic cancer stage IVB pancreatic cancer adenocarcinoma of the pancreas	Drug: glufosfamide	Phase II

Further Study Details: 

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.

PROTOCOL 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically proven metastatic or inoperable locally advanced pancreatic adenocarcinoma
• At least 1 target lesion accurately measurable in at least 1 dimension; Longest diameter at least 20 mm with conventional techniques or at least 10 mm with spiral CT scan
• No symptomatic brain metastases

--Prior/Concurrent Therapy--

• Biologic therapy: No concurrent prophylactic filgrastim (G-CSF); No concurrent prophylactic growth factors
• Chemotherapy: No prior chemotherapy for metastatic or advanced disease
• Endocrine therapy: Not specified
• Radiotherapy: At least 4 weeks since prior radiotherapy; Concurrent radiotherapy allowed provided not all target lesions are in irradiated field
• Surgery: At least 2 weeks since prior major surgery
• Other: No other concurrent anticancer agents; No other concurrent investigational therapy

--Patient Characteristics--

• Age: 18 and over
• Performance status: ECOG 0-2
• Life expectancy: At least 3 months
• Hematopoietic: Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3
• Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN); Alkaline phosphatase and transaminases no greater than 2.5 times ULN (no greater than 5 times ULN for liver metastases)
• Renal: Creatinine no greater than 1.7 mg/dL; Creatinine clearance at least 60 mL/min
• Cardiovascular: Normal cardiac function; No history of ischemic heart disease; No history of congestive heart failure within the past 6 months; Normal 12 lead electrocardiogram
• Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; No other prior or concurrent malignancy, except: Cone biopsied carcinoma of the cervix; Adequately treated basal or squamous cell skin cancer; No unstable systemic disease; No active uncontrolled infection; No psychological, familial, sociological, or geographical condition that would preclude study compliance

Denmark
      Herlev Hospital - University Hospital of Copenhagen, Herlev,  DK-2730,  Denmark
France
      Centre Eugene Marquis, Rennes,  35064,  France
      Centre Henri Becquerel, Rouen,  76038,  France
      Centre Leon Berard, Lyon,  69373,  France
      CHU de la Timone, Marseille,  13385,  France
Germany
      Haemato-Onkologische Praxis und Tagesklinik, Munich,  D-80639,  Germany
      Klinikum Nurnberg, Nuremberg,  D-90419,  Germany
      Medizinische Hochschule Hannover, Hannover,  D-30625,  Germany
      Universitats-Krankenhaus Eppendorf, Hamburg,  D-20246,  Germany
Greece
      University of Ioannina, Ioannina,  GR-45110,  Greece
Israel
      Rambam Medical Center, Haifa,  31096,  Israel
Netherlands
      Academisch Ziekenhuis der Vrije Universiteit, Amsterdam,  1117 MB,  Netherlands
Switzerland
      Centre Hospitalier Universitaire Vaudois, Lausanne,  CH-1011,  Switzerland
      Inselspital, Bern, Bern,  CH-3010,  Switzerland
      Kantonsspital - Saint Gallen, Saint Gallen,  CH-9007,  Switzerland

Study chairs or principal investigators

Nicholas A. Pavlidis,  Study Chair,  EORTC Early Clinical Studies Group   

Study ID Numbers:  CDR0000067647; EORTC-16994P; ASTA-D-19575-3166
Record last reviewed:  April 2004
Last Updated:  October 13, 2004
Record first received:  April 6, 2000
ClinicalTrials.gov Identifier:  NCT00005053
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08