Ignite Creation Date:
2024-05-05 @ 10:01 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005644
Status:
COMPLETED
Last Update Posted:
2023-06-22
First Post:
2000-05-02
Brief Title:
Combination Chemotherapy in Treating Patients With Advanced Cancer of the Urothelium and Decreased Kidney Function
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
Phase II Trial of Paclitaxel Plus Gemcitabine in Patients With Advanced Urothelial Carcinoma With Renal Insufficiency
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 cancer cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have advanced cancer of the urothelium with decreased kidney function
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have advanced cancer of the urothelium with decreased kidney function
Detailed Description:
OBJECTIVES
Determine the response rate of patients with progressive regional or metastatic transitional cell carcinoma of the urothelium with renal insufficiency when treated with paclitaxel and gemcitabine
Determine the toxicity of this regimen in this patient population
OUTLINE Patients receive paclitaxel IV over 1 hour followed immediately by gemcitabine IV over 30 minutes on days 1 8 and 15 Treatment continues every 4 weeks for a minimum of 3 courses in the absence of unacceptable toxicity or disease progression
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 10-27 patients will be accrued for this study within 10-27 months
Determine the response rate of patients with progressive regional or metastatic transitional cell carcinoma of the urothelium with renal insufficiency when treated with paclitaxel and gemcitabine
Determine the toxicity of this regimen in this patient population
OUTLINE Patients receive paclitaxel IV over 1 hour followed immediately by gemcitabine IV over 30 minutes on days 1 8 and 15 Treatment continues every 4 weeks for a minimum of 3 courses in the absence of unacceptable toxicity or disease progression
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 10-27 patients will be accrued for this study within 10-27 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 |
|---|---|---|---|
| E-5899 | None | None | None |