Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00021034
Status:
COMPLETED
Last Update Posted:
2013-06-18
First Post:
2001-07-11
Brief Title:
Taurolidine in Treating Patients With Recurrent Ovarian Epithelial Cancer Fallopian Tube Cancer or Primary Peritoneal Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Phase I Trial of Taurolidine After Positive Second Look Surgery for Recurrent Ovarian Epithelial Fallopian Tube and Primary Peritoneal Cancers
Status:
COMPLETED
Status Verified Date:
2013-06
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 I trial to study the effectiveness of taurolidine in treating patients who have recurrent ovarian epithelial cancer fallopian tube cancer or primary peritoneal cancer
PURPOSE Phase I trial to study the effectiveness of taurolidine in treating patients who have recurrent ovarian epithelial cancer fallopian tube cancer or primary peritoneal cancer
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose and recommended phase II dose of taurolidine after positive second-look surgery in patients with recurrent ovarian fallopian tube or primary peritoneal cancer II Determine the dose-limiting toxicity and safety of this drug in these patients
OUTLINE This is a dose-escalation study Patients receive taurolidine intraperitoneally weekly on weeks 1-3 and 7-9 in the absence of disease progression or unacceptable toxicity Cohorts of 1-6 patients receive escalating doses of taurolidine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity Patients are followed every 3 weeks for 9 weeks
PROJECTED ACCRUAL A maximum of 15 patients will be accrued for this study within 12-18 months
OUTLINE This is a dose-escalation study Patients receive taurolidine intraperitoneally weekly on weeks 1-3 and 7-9 in the absence of disease progression or unacceptable toxicity Cohorts of 1-6 patients receive escalating doses of taurolidine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity Patients are followed every 3 weeks for 9 weeks
PROJECTED ACCRUAL A maximum of 15 patients will be accrued for this study within 12-18 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 |
|---|---|---|---|
| NCI-G01-1976 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000068740 | REGISTRY | None | None |