Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003518
Status:
COMPLETED
Last Update Posted:
2023-06-22
First Post:
1999-11-01
Brief Title:
Paclitaxel Plus Gemcitabine in Treating Patients With Refractory Metastatic Germ Cell Tumors
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
Phase II Study of Paclitaxel Plus Gemcitabine in Refractory Germ Cell Tumors
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 paclitaxel plus gemcitabine in treating patients with refractory metastatic germ cell tumors that have not responded to surgery or chemotherapy
PURPOSE Phase II trial to study the effectiveness of paclitaxel plus gemcitabine in treating patients with refractory metastatic germ cell tumors that have not responded to surgery or chemotherapy
Detailed Description:
OBJECTIVES I Evaluate the effect of gemcitabine plus paclitaxel on response rate duration of remission and survival in patients with refractory germ cell tumors II Evaluate the toxic effects of this regimen in these patients
OUTLINE Patients receive paclitaxel IV over 1 hour followed by gemcitabine IV over 30 minutes on days 1 8 and 15 of each 4 week course Treatment is repeated for a maximum of six 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 then annually thereafter
PROJECTED ACCRUAL Approximately 44 patients will be accrued over 19 months for this study
OUTLINE Patients receive paclitaxel IV over 1 hour followed by gemcitabine IV over 30 minutes on days 1 8 and 15 of each 4 week course Treatment is repeated for a maximum of six 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 then annually thereafter
PROJECTED ACCRUAL Approximately 44 patients will be accrued over 19 months for this study
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 |
|---|---|---|---|
| E9897 | None | None | None |