Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004920
Status:
COMPLETED
Last Update Posted:
2012-07-18
First Post:
2000-03-07
Brief Title:
Cisplatin With or Without Raltitrexed in Treating Patients With Malignant Mesothelioma of the Pleura
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 III Study of Tomudex and Cisplatin Versus Cisplatin in Malignant Pleural 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 It is not yet known whether receiving cisplatin with raltitrexed is more effective than cisplatin alone for malignant mesothelioma
PURPOSE Randomized phase III trial to compare the effectiveness of cisplatin with or without raltitrexed in treating patients who have malignant mesothelioma of the pleura
PURPOSE Randomized phase III trial to compare the effectiveness of cisplatin with or without raltitrexed in treating patients who have malignant mesothelioma of the pleura
Detailed Description:
OBJECTIVES
Compare overall survival in patients with malignant pleural mesothelioma treated with raltitrexed with or without cisplatin
Assess toxicity progression free survival and quality of life with these treatment regimens in these patients
Evaluate objective response and duration of response to these treatment regimens in patients with measurable disease
OUTLINE This is a randomized open multicenter study Patients are stratified according to performance status 0 vs 1-2 and WBC count less than 8300mm3 vs 8300mm3 or more Patients are randomized to one of two treatment arms
Arm I Patients receive cisplatin IV over 1-2 hours on day 1
Arm II Patients receive raltitrexed IV over 15 minutes followed by cisplatin IV over 1-2 hours on day 1
Treatment continues every 3 weeks in the absence of disease progression or unacceptable toxicity
Quality of life is assessed before study prior to each course after the last course and then every 6 weeks for 1 year
Patients are followed every 6 weeks until death
PROJECTED ACCRUAL A total of 240 patients will be accrued for this study over 24 months
Compare overall survival in patients with malignant pleural mesothelioma treated with raltitrexed with or without cisplatin
Assess toxicity progression free survival and quality of life with these treatment regimens in these patients
Evaluate objective response and duration of response to these treatment regimens in patients with measurable disease
OUTLINE This is a randomized open multicenter study Patients are stratified according to performance status 0 vs 1-2 and WBC count less than 8300mm3 vs 8300mm3 or more Patients are randomized to one of two treatment arms
Arm I Patients receive cisplatin IV over 1-2 hours on day 1
Arm II Patients receive raltitrexed IV over 15 minutes followed by cisplatin IV over 1-2 hours on day 1
Treatment continues every 3 weeks in the absence of disease progression or unacceptable toxicity
Quality of life is assessed before study prior to each course after the last course and then every 6 weeks for 1 year
Patients are followed every 6 weeks until death
PROJECTED ACCRUAL A total of 240 patients will be accrued for this study over 24 months
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-08983 | None | None | None |