Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004081
Status:
COMPLETED
Last Update Posted:
2012-08-13
First Post:
1999-12-10
Brief Title:
Docetaxel in Treating Women With Ovarian Epithelial or Primary Peritoneal Cancer
Sponsor:
Beth Israel Deaconess Medical Center
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Phase II Trial of Weekly Low-Dose Docetaxel Taxotere in Patients With Platinum-Resistant Epithelial Ovarian or Primary Peritoneal Serous Cancer
Status:
COMPLETED
Status Verified Date:
2012-08
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 docetaxel in treating women who have ovarian epithelial cancer or primary peritoneal cancer that has not responded to previous treatment
PURPOSE Phase II trial to study the effectiveness of docetaxel in treating women who have ovarian epithelial cancer or primary peritoneal cancer that has not responded to previous treatment
Detailed Description:
OBJECTIVES
Determine the activity of docetaxel in women with platinum resistant refractory ovarian epithelial or primary peritoneal serous cancer
OUTLINE Patients receive docetaxel IV over 30 minutes on days 1 8 and 15 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients achieving complete response CR receive a minimum of 6 courses of therapy including 2 courses beyond CR
PROJECTED ACCRUAL A total of 20-30 patients will be accrued for this study within 2 years
Determine the activity of docetaxel in women with platinum resistant refractory ovarian epithelial or primary peritoneal serous cancer
OUTLINE Patients receive docetaxel IV over 30 minutes on days 1 8 and 15 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients achieving complete response CR receive a minimum of 6 courses of therapy including 2 courses beyond CR
PROJECTED ACCRUAL A total of 20-30 patients will be accrued for this study within 2 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 |
|---|---|---|---|
| NCI-V99-1565 | None | None | None |
| BIH-99-1286 | None | None | None |