Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005029
Status:
TERMINATED
Last Update Posted:
2018-04-12
First Post:
2000-04-06
Brief Title:
Topotecan in Treating Patients With Recurrent Ovarian Epithelial or Primary Peritoneal Cancer
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
Phase II Evaluation of Three-Day Topotecan NSC 609699 in Recurrent Platinum-Sensitive Ovarian or Primary Peritoneal Cancer
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 topotecan in treating patients who have recurrent ovarian epithelial or primary peritoneal cancer
PURPOSE Phase II trial to study the effectiveness of topotecan in treating patients who have recurrent ovarian epithelial or primary peritoneal cancer
Detailed Description:
OBJECTIVES I Determine the antitumor activity of topotecan in patients with recurrent platinum sensitive ovarian epithelial or primary peritoneal cancer II Determine the nature and degree of toxicity of this treatment regimen in these patients
OUTLINE Patients receive topotecan IV over 30 minutes on days 1-3 Treatment continues every 3 weeks in the absence of disease progression or unacceptable toxicity Patients are followed 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
OUTLINE Patients receive topotecan IV over 30 minutes on days 1-3 Treatment continues every 3 weeks in the absence of disease progression or unacceptable toxicity Patients are followed 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
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-0146K | None | None | None |