Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004083
Status:
COMPLETED
Last Update Posted:
2011-03-28
First Post:
1999-12-10
Brief Title:
Liposomal Cisplatin in Treating Patients With Recurrent Ovarian Cancer
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
A Phase II Pilot Study of SPI-77 Stealth Liposomal Cisplatin in Patients With Recurrent Platinum-Sensitive Ovarian Cancer
Status:
COMPLETED
Status Verified Date:
2011-03
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 liposomal cisplatin in treating patients who have recurrent ovarian cancer
PURPOSE Phase II trial to study the effectiveness of liposomal cisplatin in treating patients who have recurrent ovarian cancer
Detailed Description:
OBJECTIVES I Determine the objective response rate in patients with recurrent platinum sensitive ovarian epithelial cancer treated with cisplatin liposomal SPI-77 II Determine the time to response duration of response time to progression and survival in these patients treated with this regimen III Characterize the safety of this regimen in these patients
OUTLINE Patients receive cisplatin liposomal SPI-77 IV over a minimum of 4 hours on day 1 Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity Patients with clinical benefit after 6 courses may receive additional courses upon approval by the pharmaceutical sponsor Patients are followed every 2 months for a minimum of 6 months and then periodically for survival
PROJECTED ACCRUAL A total of 26-63 patients will be accrued for this study
OUTLINE Patients receive cisplatin liposomal SPI-77 IV over a minimum of 4 hours on day 1 Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity Patients with clinical benefit after 6 courses may receive additional courses upon approval by the pharmaceutical sponsor Patients are followed every 2 months for a minimum of 6 months and then periodically for survival
PROJECTED ACCRUAL A total of 26-63 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 |
|---|---|---|---|
| NCI-G99-1579 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA016087 |
| P30CA016087 | NIH | None | None |
| NYU-9871 | None | None | None |
| SEQUUS-77-21 | None | None | None |