Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00014599
Status:
COMPLETED
Last Update Posted:
2012-09-24
First Post:
2001-04-10
Brief Title:
Paclitaxel in Treating Patients With Locally Advanced Metastatic or Recurrent Cancer of the Vulva
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Phase II Clinical Trial On Taxol As Single Agent In Locally Advanced AndOr Metastatic Or Recurrent Vulva Cancer Not Amenable For Surgery AndOr Radiotherapy
Status:
COMPLETED
Status Verified Date:
2012-09
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
PURPOSE Phase II trial to study the effectiveness of paclitaxel in treating patients who have locally advanced metastatic or recurrent cancer of the vulva
PURPOSE Phase II trial to study the effectiveness of paclitaxel in treating patients who have locally advanced metastatic or recurrent cancer of the vulva
Detailed Description:
OBJECTIVES
Determine the therapeutic activity of paclitaxel in patients with locally advanced metastatic or recurrent squamous cell carcinoma of the vulva
Determine the objective response rate and duration of response in these patients treated with this drug
Determine the acute side effects of this drug in these patients
OUTLINE This is a multicenter study
Patients receive paclitaxel IV over 3 hours on day 1 Treatment repeats every 21 days for a maximum of 10 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 9 weeks
PROJECTED ACCRUAL A total of 16-29 patients will be accrued for this study
Determine the therapeutic activity of paclitaxel in patients with locally advanced metastatic or recurrent squamous cell carcinoma of the vulva
Determine the objective response rate and duration of response in these patients treated with this drug
Determine the acute side effects of this drug in these patients
OUTLINE This is a multicenter study
Patients receive paclitaxel IV over 3 hours on day 1 Treatment repeats every 21 days for a maximum of 10 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 9 weeks
PROJECTED ACCRUAL A total of 16-29 patients will be accrued 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 |
|---|---|---|---|
| EORTC-55985 | None | None | None |