NCT00513786

Evaluation of Carboplatin/Paclitaxel/Bevacizumab in the Treatment of Advanced Stage Endometrial Carcinoma

A Phase II Study of Carboplatin/Paclitaxel/Bevacizumab in the Treatment of Advanced Stage Endometrial Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: David O'Malley · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Purpose of this study is to determine the effectiveness of the drug combination carboplatin, paclitaxel, and bevacizumab(Avastin) in patients with advanced stage endometrial carcinoma.

Detailed description

The purpose of this study is to test the effectiveness, safety, and tolerability of the drug combination carboplatin, paclitaxel, and bevacizumab(Avastin) in patients with advanced stage endometrial carcinoma. This is a phase II,open label,single center study. Patients will receive carboplatin, paclitaxel, and bevacizumab in an outpatient center by intravenous administration. The primary objectives is to study the progression free survival at 24 months after initiation of treatment and to determine the toxicity profile of the drug combinations. The secondary objectives are to estimate the overall survival and tumor response for this group of patients.

Conditions

• Endometrial Cancer

Interventions

Type	Name	Description
DRUG	Carboplatin	AUC (area under curve) 5 Intervenous (IV) over 30 minutes given every 21 days for a maximum of 6 cycles.
DRUG	Paclitaxel	175 mg/m2 over 3 hours given every 21 days for a maximum of 6 cycles.
DRUG	bevacizumab	15 mg/kg intervenous (IV) given every 21 days for a maximum of 6 cycles.

Timeline

• Start date: 2007-08-01
• Primary completion: 2017-01-03
• Completion: 2017-01-03
• First posted: 2007-08-09
• Last updated: 2025-03-28
• Results posted: 2025-03-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study