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Home > "G" Clinical Trials Conditions > Glufosfamide With or Without Hydration in Treating Patients With Advanced Pancreatic Cancer  Glufosfamide With or Without Hydration in Treating Patients With Advanced Pancreatic Cancer
Glufosfamide With or Without Hydration in Treating Patients With Advanced Pancreatic Cancer
For Condition: adenocarcinoma of the pancreas,stage 3 pancreatic cancer,recurrent pancreatic cancer,stage 4A pancreatic cancer,stage 4B pancreatic cancer
Status: No longer recruiting
Sponsor(s): EORTC Early Clinical Studies Group ,
Synopsis: 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.
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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
NicholasPavlidis, Study Chair, EORTC Early Clinical Studies Group
Centre Henri Becquerel
Rouen, , 76038
France
Universitats-Krankenhaus Eppendorf
Hamburg, , D-20246
Germany
Haemato-Onkologische Praxis und Tagesklinik
Munich, , D-80639
Germany
Klinikum Nurnberg
Nuremberg, , D-90419
Germany
University of Ioannina
Ioannina, , GR-45110
Greece
Academisch Ziekenhuis der Vrije Universiteit
Amsterdam, , 1117 MB
Netherlands
Inselspital, Bern
Bern, , CH-3010
Switzerland
Centre Eugene Marquis
Rennes, , 35064
France
Rambam Medical Center
Haifa, , 31096
Israel
Centre Leon Berard
Lyon, , 69373
France
Herlev Hospital - University Hospital of Copenhagen
Herlev, , DK-2730
Denmark
Medizinische Hochschule Hannover
Hannover, , D-30625
Germany
Centre Hospitalier Universitaire Vaudois
Lausanne, , CH-1011
Switzerland
CHU de la Timone
Marseille, , 13385
France
Kantonsspital - Saint Gallen
Saint Gallen, , CH-9007
Switzerland
Additional Information:
Study ID Numbers: CDR0000067647; EORTC-16994P,ASTA-D-19575-3166
Study Start Date: September 2000
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005053
Other Stage 4a Pancreatic Cancer Studies:
1. Gemcitabine and Celecoxib in Treating Patients With Metastatic Pancreatic Cancer
2. Radiation Therapy in Treating Patients With Bile Duct, Gallbladder, or Pancreatic Cancer
3. Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Advanced Pancreatic Cancer
4. Glufosfamide With or Without Hydration in Treating Patients With Advanced Pancreatic Cancer
5. Fluorouracil With or Without Cisplatin in Treating Patients With Advanced or Metastatic Cancer of the Pancreas
Related Studies:
Other stage 4A pancreatic cancer Clinical Trials
Other Clinical Trials
Other Bern Clinical Trials
Glufosfamide With or Without Hydration in Treating Patients With Advanced Pancreatic Cancer
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