Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00058448
Status:
TERMINATED
Last Update Posted:
2018-06-28
First Post:
2003-04-07
Brief Title:
S0224 Docetaxel in Treating Patients With Locally Advanced or Metastatic Penile Cancer TERMINATED
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
Phase II Study Of Weekly Docetaxel In Patients With Advanced Epidermoid Carcinoma Of The Penis
Status:
TERMINATED
Status Verified Date:
2013-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study terminated due to poor patient recruitment
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 docetaxel use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of docetaxel in treating patients who have locally advanced or metastatic penile cancer
PURPOSE Phase II trial to study the effectiveness of docetaxel in treating patients who have locally advanced or metastatic penile cancer
Detailed Description:
OBJECTIVES
Determine the confirmed complete and partial response rate in patients with locally advanced or metastatic epidermoid carcinoma of the penis treated with docetaxel
Determine the progression-free and overall survival of patients treated with this drug
Determine the qualitative and quantitative toxic effects of this drug in these patients
OUTLINE Patients receive docetaxel IV over 15-30 minutes on days 1 8 and 15 Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 1 year and then every 6 months for 2 years
PROJECTED ACCRUAL A total of 20-40 patients will be accrued for this study within 3-58 years
Determine the confirmed complete and partial response rate in patients with locally advanced or metastatic epidermoid carcinoma of the penis treated with docetaxel
Determine the progression-free and overall survival of patients treated with this drug
Determine the qualitative and quantitative toxic effects of this drug in these patients
OUTLINE Patients receive docetaxel IV over 15-30 minutes on days 1 8 and 15 Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 1 year and then every 6 months for 2 years
PROJECTED ACCRUAL A total of 20-40 patients will be accrued for this study within 3-58 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 |
|---|---|---|---|
| U10CA032102 | NIH | SWOG | httpsreporternihgovquickSearchU10CA032102 |
| S0224 | OTHER | None | None |