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Glufosfamide With or Without Hydration in Treating Patients With Advanced Pancreatic Cancer

NCT ID: NCT00005053

Last Updated: 2012-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-12-31

Brief Summary

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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

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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.

Conditions

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Pancreatic Cancer

Keywords

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stage III pancreatic cancer recurrent pancreatic cancer adenocarcinoma of the pancreas stage IV pancreatic cancer

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Interventions

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glufosfamide

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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European Organisation for Research and Treatment of Cancer - EORTC

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nicholas A. Pavlidis, MD

Role: STUDY_CHAIR

University of Ioannina

Locations

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Herlev Hospital - University Hospital of Copenhagen

Herlev, , Denmark

Site Status

Centre Leon Berard

Lyon, , France

Site Status

CHU de la Timone

Marseille, , France

Site Status

Centre Eugene Marquis

Rennes, , France

Site Status

Centre Henri Becquerel

Rouen, , France

Site Status

Universitats-Krankenhaus Eppendorf

Hamburg, , Germany

Site Status

Medizinische Hochschule Hannover

Hanover, , Germany

Site Status

Haemato-Onkologische Praxis und Tagesklinik

Munich, , Germany

Site Status

Klinikum Nurnberg

Nuremberg, , Germany

Site Status

University of Ioannina

Ioannina, , Greece

Site Status

Rambam Medical Center

Haifa, , Israel

Site Status

Academisch Ziekenhuis der Vrije Universiteit

Amsterdam, , Netherlands

Site Status

Inselspital, Bern

Bern, , Switzerland

Site Status

Centre Hospitalier Universitaire Vaudois

Lausanne, , Switzerland

Site Status

Kantonsspital - Saint Gallen

Sankt Gallen, , Switzerland

Site Status

Countries

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Denmark France Germany Greece Israel Netherlands Switzerland

References

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Briasoulis E, Pavlidis N, Terret C, Bauer J, Fiedler W, Schoffski P, Raoul JL, Hess D, Selvais R, Lacombe D, Bachmann P, Fumoleau P. Glufosfamide administered using a 1-hour infusion given as first-line treatment for advanced pancreatic cancer. A phase II trial of the EORTC-new drug development group. Eur J Cancer. 2003 Nov;39(16):2334-40. doi: 10.1016/s0959-8049(03)00629-4.

Reference Type RESULT
PMID: 14556925 (View on PubMed)

Other Identifiers

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EORTC-16994P

Identifier Type: -

Identifier Source: secondary_id

ASTA-D-19575-3166

Identifier Type: -

Identifier Source: secondary_id

EORTC-16994P

Identifier Type: -

Identifier Source: org_study_id