NCT00466986

Abraxane Plus Carboplatin for Recurrent Platinum-Sensitive Ovarian Cancer

A Phase II, Non-Randomized Study of Abraxane Plus Carboplatin in Patients With Recurrent Platinum-Sensitive Ovarian or Primary Peritoneal Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Southeastern Gynecologic Oncology · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if the combination of Abraxane and Carboplatin together will improve the chances of controlling recurrent ovarian/fallopian tube/peritoneal 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 e.g. 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 day1,8,15 every 28days.

Conditions

• Ovarian Cancer
• Fallopian Tube Cancer
• Primary Peritoneal Cancer

Interventions

Type	Name	Description
DRUG	Abraxane	Carboplatin day1 every 28days. Abraxane day1,8,15 every 28days

Timeline

• Start date: 2005-11-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2007-04-27
• Last updated: 2011-10-12

Locations

1 site across 1 country: United States