Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005958
Status:
UNKNOWN
Last Update Posted:
2013-12-04
First Post:
2000-07-05
Brief Title:
Combination Chemotherapy Plus Filgrastim in Treating Patients With Locally Recurrent or Advanced Urothelium Cancer
Sponsor:
Amgen
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Treatment of Patients With Transitional-Cell Carcinoma of the Urothelial Tract With Gemcitabine Docetaxel and Filgrastim
Status:
UNKNOWN
Status Verified Date:
2001-10
Last Known Status:
ACTIVE_NOT_RECRUITING
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 Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a persons immune system recover from the side effects of chemotherapy
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy with gemcitabine and docetaxel plus filgrastim in treating patients who have locally recurrent or advanced urothelium cancer
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy with gemcitabine and docetaxel plus filgrastim in treating patients who have locally recurrent or advanced urothelium cancer
Detailed Description:
OBJECTIVES I Determine the efficacy of gemcitabine docetaxel and filgrastim G-CSF in patients with locally recurrent or advanced transitional cell carcinoma of the urothelial tract II Determine the toxicity of this regimen in these patients III Determine the disease-free and overall survival of this patient population treated with this regimen
OUTLINE This is a multicenter study Patients are stratified according to prior chemotherapy yes vs no Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8 Patients also receive filgrastim G-CSF subcutaneously daily beginning on day 9 and continuing until blood counts recover Treatment continues every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity Patients who respond to treatment may undergo surgery and 6-8 weeks later receive 2 more courses of chemotherapy Patients are followed every 3 months for 1 year
PROJECTED ACCRUAL A total of 23-40 patients who have not received prior chemotherapy and 23 patients who have received prior chemotherapy will be accrued for this study within 2 years
OUTLINE This is a multicenter study Patients are stratified according to prior chemotherapy yes vs no Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8 Patients also receive filgrastim G-CSF subcutaneously daily beginning on day 9 and continuing until blood counts recover Treatment continues every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity Patients who respond to treatment may undergo surgery and 6-8 weeks later receive 2 more courses of chemotherapy Patients are followed every 3 months for 1 year
PROJECTED ACCRUAL A total of 23-40 patients who have not received prior chemotherapy and 23 patients who have received prior chemotherapy will be accrued for this study within 2 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 |
|---|---|---|---|
| NCI-V00-1594 | None | None | None |
| AMGEN-GCSF-990125 | None | None | None |