Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002671
Status:
COMPLETED
Last Update Posted:
2012-11-09
First Post:
1999-11-01
Brief Title:
Aminocamptothecin in Treating Patients With Recurrent or Unresectable Epithelial Ovarian Cancer
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
PHASE II STUDY OF 9-20-S-AMINO-CAMPTOTHECIN 9-AC AS SECOND LINE THERAPY IN ADVANCED OVARIAN CARCINOMA
Status:
COMPLETED
Status Verified Date:
2006-05
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 aminocamptothecin in treating patients with recurrent or unresectable epithelial ovarian cancer that has been previously treated with platinum-based chemotherapy
PURPOSE Phase II trial to study the effectiveness of aminocamptothecin in treating patients with recurrent or unresectable epithelial ovarian cancer that has been previously treated with platinum-based chemotherapy
Detailed Description:
OBJECTIVES I Determine the objective response rate in patients with advanced recurrent or inoperable ovarian epithelial cancer treated with aminocamptothecin as second-line therapy II Determine the toxic effects of this regimen in these patients III Correlate the topoisomerase-I levels with response in patients with accessible tumors treated with this regimen
OUTLINE Patients are stratified according to disease measurable vs nonmeasurable The measurable disease stratum closed to accrual effective 081998 Patients receive aminocamptothecin IV continuously on days 1-3 Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity Patients who achieve complete response CR receive 4 additional courses past CR Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 60 patients 30 per stratum will be accrued for this study within approximately 15 months The measurable disease stratum closed to accrual effective 081998
OUTLINE Patients are stratified according to disease measurable vs nonmeasurable The measurable disease stratum closed to accrual effective 081998 Patients receive aminocamptothecin IV continuously on days 1-3 Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity Patients who achieve complete response CR receive 4 additional courses past CR Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 60 patients 30 per stratum will be accrued for this study within approximately 15 months The measurable disease stratum closed to accrual effective 081998
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 |
|---|---|---|---|
| NYU-9501 | None | None | None |
| E-9501 | None | None | None |
| NCI-T95-0001D | None | None | None |