Ignite Creation Date:
2024-05-05 @ 10:18 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005086
Status:
COMPLETED
Last Update Posted:
2013-09-05
First Post:
2000-04-06
Brief Title:
Combination Chemotherapy in Treating Patients With Stage IV Locally Advanced or Metastatic Bladder Cancer
Sponsor:
University of Chicago
Organization:
University of Chicago
Study Overview
Official Title:
A Phase II Trial of Sequential Doublets Chemotherapy in Patients With Locally Advanced or Metastatic Bladder Cancer
Status:
COMPLETED
Status Verified Date:
2013-09
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:
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 combination chemotherapy in treating patients who have stage IV locally advanced or metastatic bladder cancer
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have stage IV locally advanced or metastatic bladder cancer
Detailed Description:
OBJECTIVES
Determine the response rate to the combination of docetaxel and methotrexate followed by gemcitabine and cisplatin in patients with stage IV locally advanced or metastatic previously untreated transitional cell carcinoma of the urothelium
Assess the toxicities of this sequential regimen in this patient population
Assess time to event efficacy measures including time to disease progression duration of response and overall survival in these patients treated with this sequential regimen
OUTLINE Patients receive methotrexate IV on days 1 and 8 and docetaxel IV over 1 hour on day 8 every 3 weeks for 9 weeks Patients then receive cisplatin IV over 2 hours on day 1 and gemcitabine IV over 100 minutes on days 1 and 8 every 3 weeks for 9 weeks This 18 week sequential regimen constitutes 1 full course Treatment continues in the absence of unacceptable toxicity or disease progression
Patients are followed until death or until 2 years after study entry whichever comes first
PROJECTED ACCRUAL A total of 18-46 patients will be accrued for this study within 9-24 months
Determine the response rate to the combination of docetaxel and methotrexate followed by gemcitabine and cisplatin in patients with stage IV locally advanced or metastatic previously untreated transitional cell carcinoma of the urothelium
Assess the toxicities of this sequential regimen in this patient population
Assess time to event efficacy measures including time to disease progression duration of response and overall survival in these patients treated with this sequential regimen
OUTLINE Patients receive methotrexate IV on days 1 and 8 and docetaxel IV over 1 hour on day 8 every 3 weeks for 9 weeks Patients then receive cisplatin IV over 2 hours on day 1 and gemcitabine IV over 100 minutes on days 1 and 8 every 3 weeks for 9 weeks This 18 week sequential regimen constitutes 1 full course Treatment continues in the absence of unacceptable toxicity or disease progression
Patients are followed until death or until 2 years after study entry whichever comes first
PROJECTED ACCRUAL A total of 18-46 patients will be accrued for this study within 9-24 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 |
|---|---|---|---|
| NCI-G00-1733 | None | None | None |
| UCCRC-11203 | None | None | None |