Study of Intraperitoneal Carboplatin With IV Paclitaxel and Bevacizumab in Untreated Ovarian Cancer
|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: NCT01220154|
Recruitment Status : Active, not recruiting
First Posted : October 13, 2010
Last Update Posted : October 14, 2016
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Cancer No Prior Chemotherapy||Drug: Paclitaxel Drug: Carboplatin Drug: Bevacizumab||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of Intraperitoneal Carboplatin With Intravenous Paclitaxel and Bevacizumab in Patients With Previously Untreated Epithelial Ovarian Carcinoma or Primary Peritoneal Carcinoma|
|Study Start Date :||October 2010|
|Estimated Primary Completion Date :||March 2021|
Experimental: Carboplatin Paclitaxel & Bevacizumab
Intraperitoneal carboplatin with weekly intravenous paclitaxel and intravenous bevacizumab
Cycle 1 Day 1, 8, 15 IV 60-80mg mg/m2 as a 1 hour infusion. For cycle 2-6 Day 1,8,15 IV 60-80 mg/m2 as 1 hour infusion. Repeat every 3 weeks times 5 cycles.
Other Names:Drug: Carboplatin
Intraperitoneal Day 1 cycles 1-6 AUC
Other Name: Paraplatin®Drug: Bevacizumab
Bevacizumab 15 mg/kg intravenous infusion Day 1 cycles 2-6 Optional cycles 7-22 15 mg/kg intravenous infusion Day 1 every 21 days
Other Name: Avastin
- Maximum Tolerated Dose [ Time Frame: Every Cycle-28 days ]The Maximum Tolerated Dose is defined as the highest dose at which no more than 1 of 6 evaluable patients experiences a dose limiting toxicity.
- Response Rate, Progression Free Survival and Overall Survival [ Time Frame: Every 3 monthes for 2 years, Every 6 months for 3 years. ]
Response Rate in patients with measurable disease using the RECIST(Response Evaluation Criteria in Solid Tumors)criteria.
Progression free survival is also uses the RECIST criteria or GCIG criteria. Overall survival will be followed for 5 years.
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): NCT01220154
|United States, Ohio|
|OSU Gyn Oncology at Mill Run|
|Hilliard, Ohio, United States, 43026|
|Principal Investigator:||David O'Malley, MD||Ohio State University Comprehensive Cancer Center|