Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004254
Status:
COMPLETED
Last Update Posted:
2012-07-18
First Post:
2000-01-28
Brief Title:
Raltitrexed in Treating Patients With Malignant Mesothelioma That Cannot Be Surgically Removed
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Phase II Study on Tomusex in Malignant Mesothelioma
Status:
COMPLETED
Status Verified Date:
2012-07
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
PURPOSE Phase II trial to study the effectiveness of raltitrexed in treating patients who have malignant mesothelioma that cannot be surgically removed
PURPOSE Phase II trial to study the effectiveness of raltitrexed in treating patients who have malignant mesothelioma that cannot be surgically removed
Detailed Description:
OBJECTIVES I Determine the therapeutic activity and toxicities of raltitrexed in patients with inoperable malignant mesothelioma II Determine the objective response rate and duration of response in patients treated with this regimen
OUTLINE This is a multicenter study Within 2 weeks of staging procedures patients receive raltitrexed IV over 15 minutes on day 1 Treatment repeats every 3 weeks for a maximum of 8 courses in the absence of disease progression or unacceptable toxicity Patients are followed every 6 weeks until disease progression and then every 8 weeks thereafter for survival
PROJECTED ACCRUAL A total of 24 patients will be accrued for this study
OUTLINE This is a multicenter study Within 2 weeks of staging procedures patients receive raltitrexed IV over 15 minutes on day 1 Treatment repeats every 3 weeks for a maximum of 8 courses in the absence of disease progression or unacceptable toxicity Patients are followed every 6 weeks until disease progression and then every 8 weeks thereafter for survival
PROJECTED ACCRUAL A total of 24 patients 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 |
|---|---|---|---|
| EORTC-08992 | None | None | None |