Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00077129
Status:
COMPLETED
Last Update Posted:
2023-06-18
First Post:
2004-02-10
Brief Title:
Paclitaxel and Carboplatin in Treating Patients With Locally Advanced or Metastatic Renal Cell Cancer
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
Phase II Trial Of Paclitaxel Plus Carboplatin In Patients With Metastatic Or Locally Advanced Collecting Duct Renal Cell Cancer
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 such as paclitaxel and carboplatin work in different ways to stop tumor cells from dividing so they stop growing or die Giving more than one drug may kill more tumor cells
PURPOSE This phase II trial is studying how well giving paclitaxel together with carboplatin works in treating patients with locally advanced or metastatic collecting duct renal cell cancer that cannot be removed by surgery
PURPOSE This phase II trial is studying how well giving paclitaxel together with carboplatin works in treating patients with locally advanced or metastatic collecting duct renal cell cancer that cannot be removed by surgery
Detailed Description:
OBJECTIVES
Primary
Determine the response rate in patients with locally advanced or metastatic collecting duct renal cell cancer treated with paclitaxel and carboplatin
Secondary
Determine the tolerability of this regimen in these patients
OUTLINE This is an open-label multicenter study
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 Treatment repeats every 21 days for up to 6 courses in the absence of unacceptable toxicity or disease progression
Patients are followed every 3 months for 2 years and then every 6 months for 1 year
PROJECTED ACCRUAL A total of 14-22 patients will be accrued for this study within 45 years
Primary
Determine the response rate in patients with locally advanced or metastatic collecting duct renal cell cancer treated with paclitaxel and carboplatin
Secondary
Determine the tolerability of this regimen in these patients
OUTLINE This is an open-label multicenter study
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 Treatment repeats every 21 days for up to 6 courses in the absence of unacceptable toxicity or disease progression
Patients are followed every 3 months for 2 years and then every 6 months for 1 year
PROJECTED ACCRUAL A total of 14-22 patients will be accrued for this study within 45 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 |
|---|---|---|---|
| E2803 | None | None | None |