Ignite Creation Date:
2024-05-05 @ 4:48 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00313482
Status:
TERMINATED
Last Update Posted:
2012-05-11
First Post:
2006-04-10
Brief Title:
PII Trial of DocetaxelPrednisone wSargramostim for HRPC
Sponsor:
Veeda Oncology
Organization:
Veeda Oncology
Study Overview
Official Title:
A Phase II Trial of DocetaxelPrednisone in Combination With Sargramostim as Treatment for Hormone-refractory Prostate Cancer
Status:
TERMINATED
Status Verified Date:
2012-05
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:
This is a Phase II open-label study in male patients with metastatic HRPC
Each cycle will be 21 days 3 weeks Patients will receive the following drugs
Docetaxel 75 mgm2 IV given over 1 hour on Day 1
Prednisone 5 mg orally twice daily beginning on Day 1 and continuing until disease progression
Sargramostim 250 mcgm2 SC on Days 2-15 of each cycle Patients will be evaluated every 4 cycles 12 weeks for response using RECIST criteria PSA response will be evaluated according to the National Cancer Institute NCI PSA Working Group Criteria To evaluate the safety of this drug combination patients will be evaluated at each clinic visit for adverse events Toxicities will be assessed per National Cancer Institute NCI CTCAE Version 30
Those patients achieving stable disease or better will continue therapy Those patients experiencing progressive disease will be taken off study
Patients will receive a maximum of 10 cycles of treatment
Each cycle will be 21 days 3 weeks Patients will receive the following drugs
Docetaxel 75 mgm2 IV given over 1 hour on Day 1
Prednisone 5 mg orally twice daily beginning on Day 1 and continuing until disease progression
Sargramostim 250 mcgm2 SC on Days 2-15 of each cycle Patients will be evaluated every 4 cycles 12 weeks for response using RECIST criteria PSA response will be evaluated according to the National Cancer Institute NCI PSA Working Group Criteria To evaluate the safety of this drug combination patients will be evaluated at each clinic visit for adverse events Toxicities will be assessed per National Cancer Institute NCI CTCAE Version 30
Those patients achieving stable disease or better will continue therapy Those patients experiencing progressive disease will be taken off study
Patients will receive a maximum of 10 cycles of treatment
Detailed Description:
None
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