Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003054
Status:
TERMINATED
Last Update Posted:
2018-04-12
First Post:
1999-11-01
Brief Title:
Paclitaxel in Treating Patients With Recurrent or Persistent Cancer of the Uterus
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
Evaluation of Paclitaxel Taxol in the Treatment of Recurrent or Persistent Leiomyosarcoma of the Uterus
Status:
TERMINATED
Status Verified Date:
2018-04
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 paclitaxel in treating patients with recurrent or persistent cancer of the uterus
PURPOSE Phase II trial to study the effectiveness of paclitaxel in treating patients with recurrent or persistent cancer of the uterus
Detailed Description:
OBJECTIVES I Estimate the antitumor activity of paclitaxel in patients with metastatic or persistent leiomyosarcoma of the uterus who have failed treatment protocols of higher priority II Determine the nature and degree of toxic effects of paclitaxel in this group of patients
OUTLINE Patients receive a continuous infusion of paclitaxel once every 3 weeks over 3 hours Patients in complete remission partial remission or stable disease undergo at least 3 courses of paclitaxel Paclitaxel continues until disease progression or adverse effects prohibit further treatment All patients are followed until death
PROJECTED ACCRUAL This study anticipates an annual accrual of approximately 25 patients over 25 years
OUTLINE Patients receive a continuous infusion of paclitaxel once every 3 weeks over 3 hours Patients in complete remission partial remission or stable disease undergo at least 3 courses of paclitaxel Paclitaxel continues until disease progression or adverse effects prohibit further treatment All patients are followed until death
PROJECTED ACCRUAL This study anticipates an annual accrual of approximately 25 patients over 25 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-131C | None | None | None |