Ignite Creation Date:
2024-05-05 @ 9:42 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005055
Status:
COMPLETED
Last Update Posted:
2012-09-24
First Post:
2000-04-06
Brief Title:
Glufosfamide With of Without Hydration in Treating Patients With Advanced Non-small Cell Lung 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 Non Small Cell Lung 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 saline solution may protect kidney cells from the side effects of chemotherapy
PURPOSE Randomized phase II trial to study the effectiveness of glufosfamide with or without hydration in treating patients who have advanced non-small cell lung cancer
PURPOSE Randomized phase II trial to study the effectiveness of glufosfamide with or without hydration in treating patients who have advanced non-small cell lung cancer
Detailed Description:
OBJECTIVES I Determine the activity of glufosfamide as determined by objective response in patients with non-small cell lung cancer II Determine the response rate in this patient population after this treatment III Determine the duration of objective response in these patients treated with this drug IV Characterize the toxicities of this drug in these patients V Assess the impact of the hydration scheme on the toxicity profile renal function of this drug in these patients VI Assess the pharmacokinetic profile of this drug in these patients
OUTLINE This is a randomized open label multicenter study Patients are randomized to receive glufosfamide with or without hydration Arm I Patients receive glufosfamide IV over 1 hour every 3 weeks Arm II Patients receive glufosfamide as in arm I Patients are hydrated with excess physiological saline solution 4 hours before and 3 hours after treatment with glufosfamide Treatment in both arms continues for 2-6 courses in the absence of unacceptable toxicity or disease progression Patients with an objective complete response continue treatment for a maximum of 2 courses after the 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 open label multicenter study Patients are randomized to receive glufosfamide with or without hydration Arm I Patients receive glufosfamide IV over 1 hour every 3 weeks Arm II Patients receive glufosfamide as in arm I Patients are hydrated with excess physiological saline solution 4 hours before and 3 hours after treatment with glufosfamide Treatment in both arms continues for 2-6 courses in the absence of unacceptable toxicity or disease progression Patients with an objective complete response continue treatment for a maximum of 2 courses after the 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-19575-3167 | None | None | None |
| EORTC-16994N | None | None | None |