Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00087126
Status:
COMPLETED
Last Update Posted:
2019-01-08
First Post:
2004-07-08
Brief Title:
Topotecan in Treating Women With Persistent or Recurrent Cervical Cancer
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
A Phase II Evaluation of Weekly Topotecan Hydrochloride Hycamtin NSC 609699 in the Treatment of Persistent or Recurrent Carcinoma of the Cervix
Status:
COMPLETED
Status Verified Date:
2015-05
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 such as topotecan work in different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE This phase II trial is studying how well topotecan works in treating women with persistent or recurrent cervical cancer
PURPOSE This phase II trial is studying how well topotecan works in treating women with persistent or recurrent cervical cancer
Detailed Description:
OBJECTIVES
Determine the antitumor activity of topotecan in patients with persistent or recurrent carcinoma of the cervix that failed higher priority treatment protocols
Determine the nature and degree of toxicity of this drug in these patients
OUTLINE This is a multicenter study
Patients receive topotecan IV over 30 minutes on days 1 8 and 15 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patient are followed for every 3 months for 2 years and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 22-60 patients will be accrued for this study within 1-2 years
Determine the antitumor activity of topotecan in patients with persistent or recurrent carcinoma of the cervix that failed higher priority treatment protocols
Determine the nature and degree of toxicity of this drug in these patients
OUTLINE This is a multicenter study
Patients receive topotecan IV over 30 minutes on days 1 8 and 15 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patient are followed for every 3 months for 2 years and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 22-60 patients will be accrued for this study within 1-2 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 |
|---|---|---|---|
| CDR0000372930 | OTHER | CDR | None |
| GOG-0127U | None | None | None |