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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • carboplatin — DRUG
    Carboplatin AUC 5.0 or 6.0 will be administered on day 1 during cycle 1-3. Treatment cycle consists of 21 days duration.
  • Bevacizumab — DRUG
    Bevacizumab 15 mg/kg administered on Day 1 during cycle 1-3. Treatment cycle consists of 21 days duration.
  • Paclitaxel — DRUG
    60-80 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: Carboplatin
    AUC 5.0 or 6.0
  • Experimental: Bevacizumab
    15 mg/kg
  • Experimental: Paclitaxel
    60-80 mg/m2

Primary Outcome Measure

Tolerated Dose [ Time Frame: Up to 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
The Ohio State University Medical CenterColumbusOhio43210-

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