Evaluation of Carboplatin/Paclitaxel/Bevacizumab in the Treatment of Advanced Stage Endometrial Carcinoma
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Carboplatin/Paclitaxel/Bevacizumab in the Treatment of Advanced Stage Endometrial Carcinoma|
- Evaluate patients with progression free survival (PFS) [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]
- To estimate overall survival and objective tumor response using modified RECIST (Response Evaluation Criteria in Solid Tumors) criteria [ Time Frame: up to 24 months ] [ Designated as safety issue: Yes ]
- Number of patients with Adverse events as a measure of safety and tolerability. [ Time Frame: up to 24 months ] [ Designated as safety issue: Yes ]Toxicities will be assessed by using the NCI Common Toxicity Criteria for Adverse Events 3.0
|Study Start Date:||August 2007|
|Estimated Primary Completion Date:||November 2016 (Final data collection date for primary outcome measure)|
Experimental: carboplatin/paclitaxel with bevacizumab
A regimen of Carboplatin and paclitaxel combined with bevacizumab given every 21 days in patients with advanced stage endometrial cancer for a maximum of 6 cycles.
AUC (area under curve) 5 Intervenous (IV) over 30 minutes given every 21 days for a maximum of 6 cycles.
Other Names:Drug: Paclitaxel
175 mg/m2 over 3 hours given every 21 days for a maximum of 6 cycles.
Other Names:Drug: bevacizumab
15 mg/kg intervenous (IV) given every 21 days for a maximum of 6 cycles.
Other Name: Avastin
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00513786
|United States, Ohio|
|Ohio State University-Division of Gyn Oncology|
|Columbus, Ohio, United States, 43210|
|Principal Investigator:||David O'Malley, MD||The Ohio State University Division of Gyn Oncology|