Evaluation of Carboplatin/Paclitaxel/Bevacizumab in the Treatment of Advanced Stage Endometrial Carcinoma
|ClinicalTrials.gov Identifier: NCT00513786|
Recruitment Status : Completed
First Posted : August 9, 2007
Last Update Posted : August 1, 2017
|Condition or disease||Intervention/treatment||Phase|
|Endometrial Cancer||Drug: Carboplatin Drug: Paclitaxel Drug: bevacizumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||38 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Carboplatin/Paclitaxel/Bevacizumab in the Treatment of Advanced Stage Endometrial Carcinoma|
|Actual Study Start Date :||August 1, 2007|
|Primary Completion Date :||January 3, 2017|
|Study Completion Date :||January 3, 2017|
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
- Evaluate patients with progression free survival (PFS) [ Time Frame: up to 24 months ]
- To estimate overall survival and objective tumor response using modified RECIST (Response Evaluation Criteria in Solid Tumors) criteria [ Time Frame: up to 24 months ]
- Number of patients with Adverse events as a measure of safety and tolerability. [ Time Frame: up to 24 months ]Toxicities will be assessed by using the NCI Common Toxicity Criteria for Adverse Events 3.0
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|