First-line Treatment of Weekly Paclitaxel With Carboplatin and Bevacizumab in Ovarian Cancer
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|ClinicalTrials.gov Identifier: NCT01097746|
Recruitment Status : Active, not recruiting
First Posted : April 2, 2010
Last Update Posted : October 26, 2017
|Condition or disease||Intervention/treatment||Phase|
|Epithelial Ovarian Cancer Primary Peritoneal Carcinoma Fallopian Tube Cancer||Drug: Carboplatin Drug: Paclitaxel Drug: Bevacizumab||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||April 2010|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||April 2019|
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
- Number of Patients with Treatment Success [ Time Frame: 4 cycles of 21 days ]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.
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): 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|