Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003156
Status:
TERMINATED
Last Update Posted:
2013-04-11
First Post:
2000-11-06
Brief Title:
Topotecan in Treating Patients With Recurrent or Refractory Cancer of the Uterus
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
Evaluation of Topotecan in the Treatment of Persistent or Recurrent Carcinosarcoma Mixed Mesodermal Tumors of the Uterus
Status:
TERMINATED
Status Verified Date:
2006-01
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 topotecan in treating patients with recurrent or refractory cancer of the uterus
PURPOSE Phase II trial to study the effectiveness of topotecan in treating patients with recurrent or refractory cancer of the uterus
Detailed Description:
OBJECTIVES I Estimate the antitumor activity of topotecan in patients with recurrent or refractory carcinosarcoma of the uterus who have failed standard therapy II Determine the nature and degree of toxic effects of topotecan in these patients
OUTLINE Patients receive topotecan IV over 30 minutes daily for 5 days Treatment repeats every 3 weeks for a minimum of 1 course in the absence of disease progression or unacceptable toxicity Patients with complete response partial response or stable disease continue treatment for at least three courses Patients are followed every 4 months for 2 years every 6 months for 3 years and then periodically thereafter until death
PROJECTED ACCRUAL Approximately 25-40 patients will be accrued for this study within 2 years
OUTLINE Patients receive topotecan IV over 30 minutes daily for 5 days Treatment repeats every 3 weeks for a minimum of 1 course in the absence of disease progression or unacceptable toxicity Patients with complete response partial response or stable disease continue treatment for at least three courses Patients are followed every 4 months for 2 years every 6 months for 3 years and then periodically thereafter until death
PROJECTED ACCRUAL Approximately 25-40 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 |
|---|---|---|---|
| GOG-130D | None | None | None |