Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00114166
Status:
COMPLETED
Last Update Posted:
2018-07-24
First Post:
2005-06-13
Brief Title:
Topotecan in Treating Patients With Recurrent Ovarian Epithelial Fallopian Tube or Primary Peritoneal Cancer
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
A Randomized Phase II Evaluation of Topotecan NSC 609699 Administered Daily x 5 Every 3 Weeks vs Weekly Topotecan in the Treatment of Recurrent Platinum-Sensitive Ovarian Fallopian Tube or Primary Peritoneal Cancer
Status:
COMPLETED
Status Verified Date:
2014-05
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 the growth of tumor cells either by killing the cells or by stopping them from dividing Giving topotecan in different dosing schedules may kill more tumor cells
PURPOSE This phase II trial is studying how well topotecan works in treating patients with recurrent ovarian epithelial fallopian tube or primary peritoneal cancer
PURPOSE This phase II trial is studying how well topotecan works in treating patients with recurrent ovarian epithelial fallopian tube or primary peritoneal cancer
Detailed Description:
OBJECTIVES
Primary
Determine the antitumor activity of topotecan in terms of frequency and duration of tumor response in patients with recurrent platinum-sensitive ovarian epithelial fallopian tube or primary peritoneal cancer
Determine the nature and degree of toxicity of this regimen in these patients
Secondary
Determine the duration of progression-free survival and overall survival in patients treated with these regimens
Determine the effects of prognostic variables ie initial performance status age and mucinous or clear cell histology in patients treated with these regimens
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
After completion of study treatment patients are followed every 3 months for 2 years and then every 6 months for 3 years
PROJECTED ACCRUAL Approximately 38-110 patients 19-55 per treatment arm will be accrued for this study within 15-30 months
Primary
Determine the antitumor activity of topotecan in terms of frequency and duration of tumor response in patients with recurrent platinum-sensitive ovarian epithelial fallopian tube or primary peritoneal cancer
Determine the nature and degree of toxicity of this regimen in these patients
Secondary
Determine the duration of progression-free survival and overall survival in patients treated with these regimens
Determine the effects of prognostic variables ie initial performance status age and mucinous or clear cell histology in patients treated with these regimens
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
After completion of study treatment patients are followed every 3 months for 2 years and then every 6 months for 3 years
PROJECTED ACCRUAL Approximately 38-110 patients 19-55 per treatment arm will be accrued for this study within 15-30 months
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 |
|---|---|---|---|
| CDR0000434848 | None | None | None |
| GOG-0146Q | None | None | None |