Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005861
Status:
COMPLETED
Last Update Posted:
2013-06-10
First Post:
2000-06-02
Brief Title:
Liposomal Doxorubicin in Treating Patients With Advanced or Recurrent Endometrial Cancer
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
Evaluation of Doxil as First-Line Therapy of Advanced or Recurrent Endometrial Carcinoma
Status:
COMPLETED
Status Verified Date:
2002-08
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 liposomal doxorubicin in treating women who have recurrent stage III or stage IV endometrial cancer
PURPOSE Phase II trial to study the effectiveness of liposomal doxorubicin in treating women who have recurrent stage III or stage IV endometrial cancer
Detailed Description:
OBJECTIVES
Determine the antitumor activity and safety of doxorubicin HCl liposome in patients with advanced or recurrent endometrial cancer
Determine the response rate response duration and overall survival of these patients treated with this regimen
OUTLINE Patients receive doxorubicin HCl liposome IV over 1 hour Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 19-51 patients will be accrued for this study
Determine the antitumor activity and safety of doxorubicin HCl liposome in patients with advanced or recurrent endometrial cancer
Determine the response rate response duration and overall survival of these patients treated with this regimen
OUTLINE Patients receive doxorubicin HCl liposome IV over 1 hour Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 19-51 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-0086M | None | None | None |