Neoadjuvant Chemotherapy IV Carboplatin With Weekly Paclitaxel \Bevacizumab for Primary Ovarian
Part of paid clinical trials in Columbus, Ohio.
- Sponsor
- Ritu Salani
- Study ID
- NCT01219777
- Phase
- PHASE1
- Status
- Completed
Conditions
- Fallopian Tube Cancer
- Ovarian Cancer
- Primary Peritoneal Cancer
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - 90 Years
- Healthy Volunteers
- Not accepted
Interventions
- carboplatin — DRUGCarboplatin AUC 5.0 or 6.0 will be administered on day 1 during cycle 1-3. Treatment cycle consists of 21 days duration.
- Bevacizumab — DRUGBevacizumab 15 mg/kg administered on Day 1 during cycle 1-3. Treatment cycle consists of 21 days duration.
- Paclitaxel — DRUG60-80 mg/m2 administered on Day 1, 8 \& 15 during cycle 1-3. Treatment cycle consists of 21 days duration.
Study Details
The purpose of this study is to determine the maximum tolerated dose (MTD) of intravenous weekly paclitaxel given with intravenous carboplatin and bevacizumab in patients with epithelial ovarian, primary peritoneal, or fallopian tube carcinoma that are to receive neoadjuvant chemotherapy (prior to surgical cytoreduction). Patients will then undergo surgery which will allow an objective measure of response to the above regimen as well as assessment of surgical outcomes.
Key Dates
- First listed
- Oct 13, 2010
- Start date
- Sep 30, 2010
- Status verified
- May 2015
- Primary completion
- May 31, 2012
- Completion
- May 31, 2015
Study Design
- Enrollment
- 9 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: CarboplatinAUC 5.0 or 6.0
- Experimental: Bevacizumab15 mg/kg
- Experimental: Paclitaxel60-80 mg/m2
Primary Outcome Measure
Tolerated Dose [ Time Frame: Up to 6 months ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| The Ohio State University Medical Center | Columbus | Ohio | 43210 | - |
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