Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00478361
Status:
COMPLETED
Last Update Posted:
2020-10-09
First Post:
2007-05-23
Brief Title:
Gemcitabine Paclitaxel Doxorubicin in Metastatic or Unresectable Bladder Cancer With Decreased Kidney Function
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Phase II Study of Gemcitabine Paclitaxel and Doxorubicin With Pegfilgrastim for the Treatment of Patients With Metastatic Transitional Cell Carcinoma and Renal Insufficiency
Status:
COMPLETED
Status Verified Date:
2020-09
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:
This phase II trial is studying how well giving gemcitabine paclitaxel and doxorubicin together with pegfilgrastim works in treating patients with metastatic or unresectable bladder cancer or urinary tract cancer and kidney dysfunction Drugs used in chemotherapy such as gemcitabine paclitaxel and doxorubicin work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Colony stimulating factors such as pegfilgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy Giving combination chemotherapy together with pegfilgrastim may kill more tumor cells Chemotherapy drugs may have different effects in patients who have changes in their kidney function
Detailed Description:
PRIMARY OBJECTIVES
I Assess the efficacy of gemcitabine hydrochloride paclitaxel doxorubicin hydrochloride and pegfilgrastim in terms of response rate in patients with metastatic or unresectable transitional cell carcinoma of the bladder or urinary tract and renal insufficiency
SECONDARY OBJECTIVES
I Assess the safety and tolerability of this regimen in these patients II Determine the median time to progression in patients treated with this regimen
III Determine the median survival duration in patients treated with this regimen
IV Assess the safety and efficacy of pegfilgrastim in these patients
OUTLINE This is a multicenter study
Patients receive doxorubicin hydrochloride intravenous IV over 20 minutes paclitaxel IV over 60 minutes gemcitabine hydrochloride IV over 90 minutes and pegfilgrastim subcutaneously on day 1 Treatment repeats every 14 days for up to 9 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3 months for 3 years
I Assess the efficacy of gemcitabine hydrochloride paclitaxel doxorubicin hydrochloride and pegfilgrastim in terms of response rate in patients with metastatic or unresectable transitional cell carcinoma of the bladder or urinary tract and renal insufficiency
SECONDARY OBJECTIVES
I Assess the safety and tolerability of this regimen in these patients II Determine the median time to progression in patients treated with this regimen
III Determine the median survival duration in patients treated with this regimen
IV Assess the safety and efficacy of pegfilgrastim in these patients
OUTLINE This is a multicenter study
Patients receive doxorubicin hydrochloride intravenous IV over 20 minutes paclitaxel IV over 60 minutes gemcitabine hydrochloride IV over 90 minutes and pegfilgrastim subcutaneously on day 1 Treatment repeats every 14 days for up to 9 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3 months for 3 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-2009-00154 | REGISTRY | None | None |
| CDR0000544831 | None | None | None |
| 2U10CA045809-17 | NIH | CTRP Clinical Trials Reporting System | httpsreporternihgovquickSearch2U10CA045809-17 |