Evaluation of Carboplatin/Paclitaxel/Bevacizumab in the Treatment of Advanced Stage Endometrial Carcinoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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|
|Actual Primary Completion Date :||January 3, 2017|
|Actual 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|