Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004037
Status:
TERMINATED
Last Update Posted:
2013-04-11
First Post:
1999-12-10
Brief Title:
Docetaxel in Treating Patients With Recurrent or Refractory Ovarian or Primary Peritoneal Cancer
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
Evaluation of Docetaxel in Recurrent Platinum Resistant Refractory and Paclitaxel Refractory Ovarian Cancer and Primary Peritoneal Carcinoma
Status:
TERMINATED
Status Verified Date:
2003-05
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 patients with recurrent or refractory ovarian or primary peritoneal cancer
PURPOSE Phase II trial to study the effectiveness of docetaxel in treating patients with recurrent or refractory ovarian or primary peritoneal cancer
Detailed Description:
OBJECTIVES I Estimate the antitumor activity of docetaxel in patients with paclitaxel- and platinum-resistant recurrent or refractory ovarian epithelial or primary peritoneal cancer who have failed on higher priority treatment protocols II Determine the nature and degree of toxicity of docetaxel in this patient population
OUTLINE Patients receive docetaxel as a 1 hour continuous intravenous infusion Courses are repeated every 21 days Treatment continues in the absence of unacceptable toxic effects or disease progression All patients are followed every 3 months for 2 years every 6 months for 3 years and then until death
PROJECTED ACCRUAL A total of 23-56 patients will be accrued for this study
OUTLINE Patients receive docetaxel as a 1 hour continuous intravenous infusion Courses are repeated every 21 days Treatment continues in the absence of unacceptable toxic effects or disease progression All patients are followed every 3 months for 2 years every 6 months for 3 years and then until death
PROJECTED ACCRUAL A total of 23-56 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 |
|---|---|---|---|
| GOG-126J | None | None | None |