Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003723
Status:
COMPLETED
Last Update Posted:
2012-10-08
First Post:
1999-11-01
Brief Title:
S9810 Gemcitabine Plus Cisplatin in Treating Patients With Malignant Mesothelioma of the Pleura That Cannot Be Removed by Surgery
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
Phase II Study of Gemcitabine and Cisplatin in Unresectable Malignant Mesothelioma
Status:
COMPLETED
Status Verified Date:
2012-10
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 Combining more than one drug may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of gemcitabine plus cisplatin in treating patients with malignant mesothelioma of the pleura that cannot be removed by surgery
PURPOSE Phase II trial to study the effectiveness of gemcitabine plus cisplatin in treating patients with malignant mesothelioma of the pleura that cannot be removed by surgery
Detailed Description:
OBJECTIVES I Estimate overall survival and confirmed and unconfirmed complete and partial response in patients with unresectable malignant mesothelioma of the pleura treated with gemcitabine plus cisplatin II Evaluate the qualitative and quantitative toxicities of this regimen in this patient population
OUTLINE Patients receive gemcitabine IV over 30 minutes immediately followed by cisplatin IV over 30 minutes on days 1 8 and 15 Courses are repeated every 28 days Treatment continues in the absence of unacceptable toxicity or disease progression Patients with a complete response receive 2 additional courses of therapy Patients are followed every 6 months until death
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study within 25 months
OUTLINE Patients receive gemcitabine IV over 30 minutes immediately followed by cisplatin IV over 30 minutes on days 1 8 and 15 Courses are repeated every 28 days Treatment continues in the absence of unacceptable toxicity or disease progression Patients with a complete response receive 2 additional courses of therapy Patients are followed every 6 months until death
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study within 25 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 |
|---|---|---|---|
| SWOG-S9810 | OTHER | None | None |
| U10CA032102 | NIH | SWOG | httpsreporternihgovquickSearchU10CA032102 |