Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004223
Status:
COMPLETED
Last Update Posted:
2023-06-18
First Post:
2000-01-28
Brief Title:
Docetaxel and Gemcitabine in Treating Patients With Progressive Regional or Metastatic Bladder Cancer
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
Phase II Trial of Gemcitabine and Docetaxel in Advanced Carcinoma of the Urothelium
Status:
COMPLETED
Status Verified Date:
2023-06
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 docetaxel and gemcitabine in treating patients who have progressive regional or metastatic bladder cancer
PURPOSE Phase II trial to study the effectiveness of docetaxel and gemcitabine in treating patients who have progressive regional or metastatic bladder cancer
Detailed Description:
OBJECTIVES I Determine the response rate of patients with progressive regional or metastatic transitional cell carcinoma of the urothelium and failure of only 1 prior systemic regimen treated with docetaxel and gemcitabine II Determine the toxicities of this regimen in these patients
OUTLINE This is a multicenter study Patients receive docetaxel IV over 1 hour followed by gemcitabine IV over 30 minutes on days 1 and 8 For patients with complete or partial response or stable disease at 3 weeks treatment repeats every 3 weeks for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity Patients are followed every 3 months through year 2 every 6 months through year 5 and then annually thereafter until disease progression
PROJECTED ACCRUAL A total of 22-45 patients will be accrued for this study over 18-21 months
OUTLINE This is a multicenter study Patients receive docetaxel IV over 1 hour followed by gemcitabine IV over 30 minutes on days 1 and 8 For patients with complete or partial response or stable disease at 3 weeks treatment repeats every 3 weeks for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity Patients are followed every 3 months through year 2 every 6 months through year 5 and then annually thereafter until disease progression
PROJECTED ACCRUAL A total of 22-45 patients will be accrued for this study over 18-21 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 |
|---|---|---|---|
| E-2899 | None | None | None |