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

Primary Purpose

Pancreatic Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
glufosfamide
Sponsored by
European Organisation for Research and Treatment of Cancer - EORTC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring stage III pancreatic cancer, recurrent pancreatic cancer, adenocarcinoma of the pancreas, stage IV pancreatic cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Herlev Hospital - University Hospital of Copenhagen
  • Centre Leon Berard
  • CHU de la Timone
  • Centre Eugene Marquis
  • Centre Henri Becquerel
  • Universitats-Krankenhaus Eppendorf
  • Medizinische Hochschule Hannover
  • Haemato-Onkologische Praxis und Tagesklinik
  • Klinikum Nurnberg
  • University of Ioannina
  • Rambam Medical Center
  • Academisch Ziekenhuis der Vrije Universiteit
  • Inselspital, Bern
  • Centre Hospitalier Universitaire Vaudois
  • Kantonsspital - Saint Gallen

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 6, 2000
Last Updated
September 20, 2012
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
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1. Study Identification

Unique Protocol Identification Number
NCT00005053
Brief Title
Glufosfamide With or Without Hydration in Treating Patients With Advanced Pancreatic Cancer
Official Title
Open Label Phase II Study on Glufosfamide Administered as a 60 Minute Infusion Every 3 Weeks in Advanced Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
December 1999 (undefined)
Primary Completion Date
March 2001 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Organisation for Research and Treatment of Cancer - EORTC

4. Oversight

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
stage III pancreatic cancer, recurrent pancreatic cancer, adenocarcinoma of the pancreas, stage IV pancreatic cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
glufosfamide

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicholas A. Pavlidis, MD
Organizational Affiliation
University of Ioannina
Official's Role
Study Chair
Facility Information:
Facility Name
Herlev Hospital - University Hospital of Copenhagen
City
Herlev
ZIP/Postal Code
DK-2730
Country
Denmark
Facility Name
Centre Leon Berard
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
CHU de la Timone
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
Centre Eugene Marquis
City
Rennes
ZIP/Postal Code
35064
Country
France
Facility Name
Centre Henri Becquerel
City
Rouen
ZIP/Postal Code
76038
Country
France
Facility Name
Universitats-Krankenhaus Eppendorf
City
Hamburg
ZIP/Postal Code
D-20246
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
D-30625
Country
Germany
Facility Name
Haemato-Onkologische Praxis und Tagesklinik
City
Munich
ZIP/Postal Code
D-80639
Country
Germany
Facility Name
Klinikum Nurnberg
City
Nuremberg
ZIP/Postal Code
D-90419
Country
Germany
Facility Name
University of Ioannina
City
Ioannina
ZIP/Postal Code
GR-45110
Country
Greece
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Academisch Ziekenhuis der Vrije Universiteit
City
Amsterdam
ZIP/Postal Code
1117 MB
Country
Netherlands
Facility Name
Inselspital, Bern
City
Bern
ZIP/Postal Code
CH-3010
Country
Switzerland
Facility Name
Centre Hospitalier Universitaire Vaudois
City
Lausanne
ZIP/Postal Code
CH-1011
Country
Switzerland
Facility Name
Kantonsspital - Saint Gallen
City
Saint Gallen
ZIP/Postal Code
CH-9007
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
14556925
Citation
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.
Results Reference
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Glufosfamide With or Without Hydration in Treating Patients With Advanced Pancreatic Cancer

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