Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00110123
Status:
TERMINATED
Last Update Posted:
2012-09-24
First Post:
2005-05-03
Brief Title:
Intravenous or Hepatic Arterial Infusion of Fotemustine in Treating Patients With Unresectable Liver Metastases From Eye Melanoma
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Intravenous Versus Intra-Arterial Fotemustine Chemotherapy in Patients With Liver Metastases From Uveal Melanoma A Randomized Phase III Study of the EORTC Melanoma Group
Status:
TERMINATED
Status Verified Date:
2012-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
low accrual
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 such as fotemustine work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving the drugs in different ways may kill more tumor cells It is not yet known whether giving fotemustine as an intravenous infusion is more effective than giving it as a hepatic arterial infusion in treating liver metastases
PURPOSE This randomized phase III trial is studying intravenous infusion of fotemustine to see how well it works compared to hepatic arterial infusion of fotemustine in treating patients with unresectable liver metastases from eye melanoma
PURPOSE This randomized phase III trial is studying intravenous infusion of fotemustine to see how well it works compared to hepatic arterial infusion of fotemustine in treating patients with unresectable liver metastases from eye melanoma
Detailed Description:
OBJECTIVES
Primary
Compare overall survival of patients with surgically incurable or unresectable liver metastases secondary to uveal melanoma treated with fotemustine administered as an intravenous infusion vs an intra-arterial hepatic perfusion
Secondary
Compare progression-free survival of patients treated with this drug
Compare the response rate in patients treated with this drug
Compare the duration of objective response in patients treated with this drug
Compare the patterns of progression in patients treated with this drug
Compare treatment-related toxic effects and catheter-related complications in patients treated with this drug
OUTLINE This is an open-label randomized multicenter study Patients are stratified according to participating center lactic dehydrogenase level normal vs abnormal and WHO performance status 0 vs 1 vs 2 Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive fotemustine IV over 1 hour on days 1 8 and 15 induction course Beginning on day 50 patients receive maintenance courses of fotemustine IV over 1 hour every 21 days in the absence of disease progression or unacceptable toxicity
Arm II Patients receive fotemustine by a 4-hour intra-arterial IA hepatic perfusion on days 1 8 15 and 22 induction course Beginning on day 57 patients receive maintenance courses of fotemustine by a 4-hour IA hepatic perfusion every 21 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 9 weeks for survival
PROJECTED ACCRUAL A total of 262 patients 131 per treatment arm will be accrued for this study within 3 years
Primary
Compare overall survival of patients with surgically incurable or unresectable liver metastases secondary to uveal melanoma treated with fotemustine administered as an intravenous infusion vs an intra-arterial hepatic perfusion
Secondary
Compare progression-free survival of patients treated with this drug
Compare the response rate in patients treated with this drug
Compare the duration of objective response in patients treated with this drug
Compare the patterns of progression in patients treated with this drug
Compare treatment-related toxic effects and catheter-related complications in patients treated with this drug
OUTLINE This is an open-label randomized multicenter study Patients are stratified according to participating center lactic dehydrogenase level normal vs abnormal and WHO performance status 0 vs 1 vs 2 Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive fotemustine IV over 1 hour on days 1 8 and 15 induction course Beginning on day 50 patients receive maintenance courses of fotemustine IV over 1 hour every 21 days in the absence of disease progression or unacceptable toxicity
Arm II Patients receive fotemustine by a 4-hour intra-arterial IA hepatic perfusion on days 1 8 15 and 22 induction course Beginning on day 57 patients receive maintenance courses of fotemustine by a 4-hour IA hepatic perfusion every 21 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 9 weeks for survival
PROJECTED ACCRUAL A total of 262 patients 131 per treatment arm will be accrued for this study within 3 years
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 |
|---|---|---|---|
| 2004-002245-12 | EUDRACT_NUMBER | None | None |
| EORTC-18021 | None | None | None |