First-line Treatment of Weekly Paclitaxel With Carboplatin and Bevacizumab in Ovarian Cancer
The goal of this clinical research study is to learn if therapy with bevacizumab, carboplatin, and weekly doses of paclitaxel is safe and can be tolerated in patients with newly diagnosed epithelial ovarian, primary peritoneal, or fallopian tube cancer. Researchers will also study if and how well this study therapy may help to control the disease.
Epithelial Ovarian Cancer
Primary Peritoneal Carcinoma
Fallopian Tube Cancer
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of Bevacizumab With Carboplatin and Weekly Paclitaxel as First-Line Treatment in Epithelial Ovarian, Primary Peritoneal, and Fallopian Tube Carcinoma|
- Number of Patients with Treatment Success [ Time Frame: 4 cycles of 21 days ] [ Designated as safety issue: Yes ]Treatment Success is defined as a patient completing at least 4 cycles of combination therapy (Bevacizumab with Carboplatin and weekly Paclitaxel) regardless of delay or dose modification.
|Study Start Date:||April 2010|
|Estimated Primary Completion Date:||June 2017 (Final data collection date for primary outcome measure)|
Experimental: Bevacizumab + Carboplatin + Paclitaxel
Carboplatin AUC 5 by vein Day 1 of Cycles 1-6. Paclitaxel 80 mg/m2 by vein (IV) over about 3 hours on Day 1 followed by Carboplatin, then on Days 8 and 15 of Cycle 1 Paclitaxel alone. On Day 1 of Cycles 2-6 Paclitaxel is followed by Carboplatin and Bevacizumab, then on Days 8 and 15 only Paclitaxel.
Bevacizumab 15 mg/kg IV over about 1 ½ hours on Day 1 of Cycles 2-6.
AUC 5 by vein Day 1 of Cycles 1-6.
Other Name: ParaplatinDrug: Paclitaxel
80 mg/m2 by vein (IV) over about 3 hours on Day 1 followed by Carboplatin, then on Days 8 and 15 of Cycle 1 Paclitaxel alone. On Day 1 of Cycles 2-6 Paclitaxel is followed by Carboplatin and Bevacizumab, then on Days 8 and 15 only Paclitaxel.
Other Name: TaxolDrug: Bevacizumab
15 mg/kg IV over about 1 ½ hours on Day 1 of Cycles 2-6.
Other Name: Avastin
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01097746
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Anil Sood, MD||M.D. Anderson Cancer Center|