Ignite Creation Date:
2024-05-05 @ 5:28 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00466986
Status:
COMPLETED
Last Update Posted:
2011-10-12
First Post:
2007-04-26
Brief Title:
Abraxane Plus Carboplatin for Recurrent Platinum-Sensitive Ovarian Cancer
Sponsor:
Southeastern Gynecologic Oncology
Organization:
Southeastern Gynecologic Oncology
Study Overview
Official Title:
A Phase II Non-Randomized Study of Abraxane Plus Carboplatin in Patients With Recurrent Platinum-Sensitive Ovarian or Primary Peritoneal Cancer
Status:
COMPLETED
Status Verified Date:
2011-10
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:
The purpose of this study is to determine if the combination of Abraxane and Carboplatin together will improve the chances of controlling recurrent ovarianfallopian tubeperitoneal cancer
Detailed Description:
Current best practice recommends Carboplatin combined with Taxol in the treatment of Ovarian cancer
Taxol is paclitaxel in the solvent Cremophor-El and the solvent has been associated with significant side effects eg anaphylaxis and hypersensitivity this requires the routine use of premedication with antihistamines and steroids
Abraxane by contrast is Cremophor-El free and is protein bound This has 2 advantages over Taxol
1 No need for routine premedications
2 Increased drug entry into cells facilitating greater potential for anti-tumor activity
Schedule Carboplatin day1 every 28days Abraxane day1815 every 28days
Taxol is paclitaxel in the solvent Cremophor-El and the solvent has been associated with significant side effects eg anaphylaxis and hypersensitivity this requires the routine use of premedication with antihistamines and steroids
Abraxane by contrast is Cremophor-El free and is protein bound This has 2 advantages over Taxol
1 No need for routine premedications
2 Increased drug entry into cells facilitating greater potential for anti-tumor activity
Schedule Carboplatin day1 every 28days Abraxane day1815 every 28days
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