Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005643
Status:
COMPLETED
Last Update Posted:
2013-06-10
First Post:
2000-05-02
Brief Title:
Chemotherapy in Treating Patients With Sarcoma of the Uterus
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
Evaluation of Doxil in the Treatment of Recurrent or Advanced Leiomyosarcoma of the Uterus
Status:
COMPLETED
Status Verified Date:
2005-11
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 patients who have advanced or recurrent sarcoma of the uterus
PURPOSE Phase II trial to study the effectiveness of liposomal doxorubicin in treating patients who have advanced or recurrent sarcoma of the uterus
Detailed Description:
OBJECTIVES I Estimate the antitumor activity of doxorubicin HCl liposome in patients with recurrent or advanced uterine sarcoma II Determine the nature and degree of toxicity of this drug in this patient population
OUTLINE Patients receive doxorubicin HCl liposome IV over 1 hour Treatment continues every 4 weeks in the absence of unacceptable toxicity or disease progression Patients are followed every 3 months for 2 years and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 20-30 patients will be accrued for this study within 1-15 years
OUTLINE Patients receive doxorubicin HCl liposome IV over 1 hour Treatment continues every 4 weeks in the absence of unacceptable toxicity or disease progression Patients are followed every 3 months for 2 years and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 20-30 patients will be accrued for this study within 1-15 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 |
|---|---|---|---|
| GOG-0087J | None | None | None |