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Sponsored by: |
European Organization for Research and Treatment of Cancer |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00005053 |
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 | Intervention | Phase |
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Pancreatic Cancer |
Drug: glufosfamide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
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 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
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
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
Denmark | |
Herlev Hospital - University Hospital of Copenhagen | |
Herlev, Denmark, DK-2730 | |
France | |
Centre Eugene Marquis | |
Rennes, France, 35064 | |
Centre Henri Becquerel | |
Rouen, France, 76038 | |
Centre Leon Berard | |
Lyon, France, 69373 | |
CHU de la Timone | |
Marseille, France, 13385 | |
Germany | |
Haemato-Onkologische Praxis und Tagesklinik | |
Munich, Germany, D-80639 | |
Klinikum Nurnberg | |
Nuremberg, Germany, D-90419 | |
Medizinische Hochschule Hannover | |
Hannover, Germany, D-30625 | |
Universitats-Krankenhaus Eppendorf | |
Hamburg, Germany, D-20246 | |
Greece | |
University of Ioannina | |
Ioannina, Greece, GR-45110 | |
Israel | |
Rambam Medical Center | |
Haifa, Israel, 31096 | |
Netherlands | |
Academisch Ziekenhuis der Vrije Universiteit | |
Amsterdam, Netherlands, 1117 MB | |
Switzerland | |
Centre Hospitalier Universitaire Vaudois | |
Lausanne, Switzerland, CH-1011 | |
Inselspital, Bern | |
Bern, Switzerland, CH-3010 | |
Kantonsspital - Saint Gallen | |
Saint Gallen, Switzerland, CH-9007 |
Study Chair: | Nicholas A. Pavlidis, MD | University of Ioannina |
Study ID Numbers: | CDR0000067647, EORTC-16994P, ASTA-D-19575-3166 |
Study First Received: | April 6, 2000 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00005053 History of Changes |
Health Authority: | United States: Federal Government |
stage III pancreatic cancer recurrent pancreatic cancer adenocarcinoma of the pancreas stage IV pancreatic cancer |
Digestive System Diseases Digestive System Neoplasms Pancreatic Neoplasms Endocrine System Diseases Pancreatic Diseases Gastrointestinal Neoplasms |
Endocrinopathy Adenocarcinoma Pancrelipase Recurrence Endocrine Gland Neoplasms |
Neoplasms Digestive System Diseases Neoplasms by Site Digestive System Neoplasms |
Pancreatic Neoplasms Endocrine System Diseases Pancreatic Diseases Endocrine Gland Neoplasms |