Ignite Creation Date:
2024-05-05 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00499252
Status:
COMPLETED
Last Update Posted:
2018-01-11
First Post:
2007-07-10
Brief Title:
Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer Fallopian Tube Cancer or Primary Peritoneal Cancer
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
A Phase II Evaluation of Abraxane in the Treatment of Recurrent or Persistent Platinum-Resistant Ovarian Fallopian Tube or Primary Peritoneal Cancer
Status:
COMPLETED
Status Verified Date:
2015-03
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:
This phase II trial is studying the side effects and how well paclitaxel albumin-stabilized nanoparticle formulation works in treating patients with recurrent or persistent ovarian epithelial cancer fallopian tube cancer or primary peritoneal cancer Drugs used in chemotherapy such as paclitaxel albumin-stabilized nanoparticle formulation work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing
Detailed Description:
PRIMARY OBJECTIVES
I Determine the antitumor activity of paclitaxel albumin-stabilized nanoparticle formulation Abraxane in terms of frequency and duration of objective response in patients with persistent or recurrent platinum-resistant ovarian epithelial fallopian tube or primary peritoneal cancer
II Determine the toxicity of this drug in these patients
SECONDARY OBJECTIVES
I Determine the duration of progression-free survival and overall survival of patients treated with this drug
OUTLINE This is a multicenter study
Patients receive paclitaxel albumin-stabilized nanoparticle formulation Abraxane IV over 30 minutes on days 1 8 and 15 Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3 months for 2 years and then every 6 months for 3 years
I Determine the antitumor activity of paclitaxel albumin-stabilized nanoparticle formulation Abraxane in terms of frequency and duration of objective response in patients with persistent or recurrent platinum-resistant ovarian epithelial fallopian tube or primary peritoneal cancer
II Determine the toxicity of this drug in these patients
SECONDARY OBJECTIVES
I Determine the duration of progression-free survival and overall survival of patients treated with this drug
OUTLINE This is a multicenter study
Patients receive paclitaxel albumin-stabilized nanoparticle formulation Abraxane IV over 30 minutes on days 1 8 and 15 Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3 months for 2 years and then every 6 months for 3 years
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 |
|---|---|---|---|
| U10CA027469 | NIH | CTEP | httpsreporternihgovquickSearchU10CA027469 |
| NCI-2009-00575 | REGISTRY | None | None |
| ABRAXIS-ABX-005 | None | None | None |
| CDR0000553208 | None | None | None |
| GOG-0126R | OTHER | None | None |
| GOG-0126R | OTHER | None | None |