Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005053
Status:
COMPLETED
Last Update Posted:
2012-09-24
First Post:
2000-04-06
Brief Title:
Glufosfamide With or Without Hydration in Treating Patients With Advanced Pancreatic Cancer
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Open Label Phase II Study on Glufosfamide Administered as a 60 Minute Infusion Every 3 Weeks in Advanced Pancreatic Cancer
Status:
COMPLETED
Status Verified Date:
2012-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ASTA-D-19575-3166 | None | None | None |
| EORTC-16994P | None | None | None |