Pancreatic CancerPhase 2NCT00005053
Glufosfamide With or Without Hydration in Treating Patients With Advanced Pancreatic Cancer
A Phase 2 study testing glufosfamide in people with Pancreatic Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 15 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- glufosfamide
- How many people
- 35 participants
- Where
- 15 sitesin 7 countries
- Study dates
- Dec 1999to Mar 2001
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
15 sites in 7 countries.
15 sites in 7 countries
France4 sites
Centre Leon Berard
Lyon, 69373
CHU de la Timone
Marseille, 13385
Centre Eugene Marquis
Rennes, 35064
Centre Henri Becquerel
Rouen, 76038
Germany4 sites
Universitats-Krankenhaus Eppendorf
Hamburg, D-20246
Medizinische Hochschule Hannover
Hanover, D-30625
Haemato-Onkologische Praxis und Tagesklinik
Munich, D-80639
Klinikum Nurnberg
Nuremberg, D-90419
Switzerland3 sites
Inselspital, Bern
Bern, CH-3010
Centre Hospitalier Universitaire Vaudois
Lausanne, CH-1011
Kantonsspital - Saint Gallen
Sankt Gallen, CH-9007
Denmark1 site
Herlev Hospital - University Hospital of Copenhagen
Herlev, DK-2730
Netherlands1 site
Academisch Ziekenhuis der Vrije Universiteit
Amsterdam, 1117 MB
About this study
Official title: Open Label Phase II Study on Glufosfamide Administered as a 60 Minute Infusion Every 3 Weeks in Advanced Pancreatic Cancer
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.
Read the 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.
- Conditions
- Pancreatic Cancer
- Being tested
- glufosfamide
- Keywords
- stage III pancreatic cancer, recurrent pancreatic cancer, adenocarcinoma of the pancreas, stage IV pancreatic cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glufosfamideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2004 (estimated)
- Study startDec 1999
- Primary completionMar 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Nicholas A. Pavlidis, MD, Study chair, University of Ioannina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005053
- Sponsor's protocol ID
- EORTC-16994P
- Other IDs
- EORTC-16994P, ASTA-D-19575-3166
- Status last verified
- Sep 2012
- First submitted
- 6 Apr 2000
- Last updated
- 24 Sep 2012
- Results posted
- No
Publications
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.
PubMed 14556925
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Phase II Study on Glufosfamide Administered as a 60 Minute Infusion Every 3 Weeks in Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT00005053
- Acronym / sponsor ID
- EORTC-16994P
- Conditions
- Pancreatic Cancer
- Keywords
- stage III pancreatic cancer, recurrent pancreatic cancer, adenocarcinoma of the pancreas, stage IV pancreatic cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Study start
- Dec 1999
- Primary completion
- Mar 2001 (actual)
- First posted
- 3 May 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| glufosfamide | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2012.
- Results publication: PubMed 14556925Briasoulis 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.
Related trials for Pancreatic Cancer
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1
A Study of MGC030 in Participants With Advanced Solid Tumors
Urothelial Cancer, GastroEsophageal Cancer
Recruiting
Implementation of a Pain Management Plan in Major Open Abdominal Surgeries.
Abdomen Cancer, Pancreas Adenocarcinoma (MSI-H)
Active, not recruitingPhase 2
Pembrolizumab With Olaparib as Combined Therapy in Metastatic Pancreatic Cancer
Pancreatic Cancer
RecruitingPhase 2/3
Zanzalintinib Versus Everolimus in Participants With Locally Advanced or Metastatic Neuroendocrine Tumors
Pancreatic Neuroendocrine Tumor (pNET), Extra-Pancreatic Neuroendocrine Tumor (epNET)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicholas A. Pavlidis, MD study chair
University of Ioannina
15 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing glufosfamide in people with Pancreatic Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 15 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in France, Germany, Switzerland, Denmark, Greece and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005053, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2012.