Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003316
Status:
TERMINATED
Last Update Posted:
2013-04-11
First Post:
2000-11-06
Brief Title:
Gemcitabine in Treating Patients With Recurrent or Refractory Cancer of the Uterus
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
Evaluation of Gemcitabine in the Treatment of Recurrent or Persistent Leiomyosarcoma of the Uterus
Status:
TERMINATED
Status Verified Date:
2004-05
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 gemcitabine in treating patients with recurrent or refractory cancer of the uterus
PURPOSE Phase II trial to study the effectiveness of gemcitabine in treating patients with recurrent or refractory cancer of the uterus
Detailed Description:
OBJECTIVES I Determine the antitumor activity of gemcitabine in patients with recurrent or persistent leiomyosarcoma of the uterus who failed higher priority treatment protocols II Determine the toxicity of gemcitabine in these patients
OUTLINE Patients receive gemcitabine IV over 30 minutes weekly for 3 weeks Courses repeat every 4 weeks in the absence of unacceptable toxicity and disease progression Patients with partial response complete response or stable disease receive at least 3 courses of therapy Patients are followed every 3 months for 2 years then every 6 months for 3 years
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study within 4 years
OUTLINE Patients receive gemcitabine IV over 30 minutes weekly for 3 weeks Courses repeat every 4 weeks in the absence of unacceptable toxicity and disease progression Patients with partial response complete response or stable disease receive at least 3 courses of therapy Patients are followed every 3 months for 2 years then every 6 months for 3 years
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study within 4 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-131E | None | None | None |