Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00021385
Status:
UNKNOWN
Last Update Posted:
2013-12-18
First Post:
2001-07-11
Brief Title:
Squalamine Lactate Plus Carboplatin in Treating Patients With Recurrent or Refractory Stage III or Stage IV Ovarian Cancer
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase IIA Trial of Continuous Five Day Infusions of MSI-1256F Squalamine Lactate Plus Carboplatin for Therapy of Refractory and Resistant Stage III and IV Ovarian Cancer
Status:
UNKNOWN
Status Verified Date:
2002-05
Last Known Status:
ACTIVE_NOT_RECRUITING
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 Squalamine lactate may stop or slow the growth of ovarian cancer by stopping blood flow to the tumor Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining squalamine lactate with carboplatin may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combining squalamine lactate and carboplatin in treating patients who have recurrent or refractory stage III or stage IV ovarian cancer
PURPOSE Phase II trial to study the effectiveness of combining squalamine lactate and carboplatin in treating patients who have recurrent or refractory stage III or stage IV ovarian cancer
Detailed Description:
OBJECTIVES I Determine the response rate and time to progression in patients with recurrent or refractory stage III or IV ovarian cancer treated with squalamine lactate and carboplatin II Determine the safety profile of this regimen in these patients
OUTLINE Patients receive carboplatin IV over 15-30 minutes on day 1 and squalamine lactate IV continuously on days 1-5 Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity Patients are followed at approximately 1 month
PROJECTED ACCRUAL Approximately 45 patients will be accrued for this study
OUTLINE Patients receive carboplatin IV over 15-30 minutes on day 1 and squalamine lactate IV continuously on days 1-5 Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity Patients are followed at approximately 1 month
PROJECTED ACCRUAL Approximately 45 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-G01-1987 | None | None | None |
| UCLA-0001004 | None | None | None |
| MAGA-MSI-1256F-203 | None | None | None |