Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006118
Status:
UNKNOWN
Last Update Posted:
2008-07-24
First Post:
2000-08-03
Brief Title:
Cisplatin Paclitaxel and Gemcitabine in Treating Patients With Progressive Unresectable Regional or Metastatic Bladder Cancer
Sponsor:
GERCOR - Multidisciplinary Oncology Cooperative Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
First Line Treatment of Locally Advanced or Metastatic Urothelial Carcinoma of the Bladder With a Combination of Cisplatin-Paclitaxel-Gemcitabine
Status:
UNKNOWN
Status Verified Date:
2001-11
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 Combining more than one drug may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combining cisplatin paclitaxel and gemcitabine in treating patients who have progressive unresectable regional or metastatic bladder cancer
PURPOSE Phase II trial to study the effectiveness of combining cisplatin paclitaxel and gemcitabine in treating patients who have progressive unresectable regional or metastatic bladder cancer
Detailed Description:
OBJECTIVES
Determine the efficacy and toxicity of cisplatin paclitaxel and gemcitabine in patients with progressive unresectable regional or metastatic transitional cell carcinoma of the bladder
Determine the progression free survival of these patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and cisplatin IV over 1 hour and paclitaxel IV over 3 hours on day 1 Treatment repeats every 3 weeks for 6 courses
Patients are followed every 3 months until disease progression
PROJECTED ACCRUAL A total of 39 patients will be accrued for this study within 18 months
Determine the efficacy and toxicity of cisplatin paclitaxel and gemcitabine in patients with progressive unresectable regional or metastatic transitional cell carcinoma of the bladder
Determine the progression free survival of these patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and cisplatin IV over 1 hour and paclitaxel IV over 3 hours on day 1 Treatment repeats every 3 weeks for 6 courses
Patients are followed every 3 months until disease progression
PROJECTED ACCRUAL A total of 39 patients will be accrued for this study within 18 months
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| FRE-GERCOR-U99-1 | None | None | None |
| EU-20030 | None | None | None |