Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005046
Status:
COMPLETED
Last Update Posted:
2013-05-27
First Post:
2000-04-06
Brief Title:
Paclitaxel in Treating Patients With Recurrent or Persistent Ovarian or Primary Peritoneal Cancer
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
A Phase I Open Label Assessment of the Safety and Pharmacokinetics of Intraperitoneal PACLIMER Microspheres PolilactofatePaclitaxel in Patients With Ovarian Cancer
Status:
COMPLETED
Status Verified Date:
2008-07
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 paclitaxel in treating patients who have recurrent or persistent ovarian or primary peritoneal cancer
PURPOSE Phase I trial to study the effectiveness of paclitaxel in treating patients who have recurrent or persistent ovarian or primary peritoneal cancer
Detailed Description:
OBJECTIVES I Determine the safety and tolerability of intraperitoneal administration of paclitaxel Paclimer microspheres in patients with recurrent or persistent ovarian or primary peritoneal carcinoma II Determine and confirm the maximum tolerated dose of this regimen in this patient population III Determine plasma paclitaxel concentrations at selected times after intraperitoneal administration of Paclimer microspheres in these patients
OUTLINE This is a dose escalation study Patients receive intraperitoneal paclitaxel Paclimer microspheres every 8 weeks for 2 courses Cohorts of 1-3 patients receive escalating doses of intraperitoneal paclitaxel Paclimer microspheres until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 patients experience dose limiting toxicities Once the probable MTD is determined an additional cohort of 8 patients is accrued to confirm the MTD The MTD is confirmed as the dose level at which at least 6 of 8 patients demonstrate acceptable safety and tolerability
PROJECTED ACCRUAL A maximum of 24 patients will be accrued for this study
OUTLINE This is a dose escalation study Patients receive intraperitoneal paclitaxel Paclimer microspheres every 8 weeks for 2 courses Cohorts of 1-3 patients receive escalating doses of intraperitoneal paclitaxel Paclimer microspheres until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 patients experience dose limiting toxicities Once the probable MTD is determined an additional cohort of 8 patients is accrued to confirm the MTD The MTD is confirmed as the dose level at which at least 6 of 8 patients demonstrate acceptable safety and tolerability
PROJECTED ACCRUAL A maximum of 24 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 |
|---|---|---|---|
| GP-700-9901 | None | None | None |
| GOG-9904 | None | None | None |