Phase I Study of Intraperitoneal Carboplatin With Intravenous Paclitaxel and Bevacizumab in Patients With Previously Untreated Epithelial Ovarian Carcinoma or Primary Peritoneal Carcinoma
Phase I study with the primary objective to determine the maximum tolerated dose of
intraperitoneal carboplatin and intravenous weekly paclitaxel given in combination with
intravenous bevacizumab during the second two cycles of treatment in patients with
chemo-naive epithelial ovarian, primary peritoneal or fallopian tube cancer. 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 during the second two cycles of treatment.
Secondary objectives are to determine response rates and to estimate progression free
survival and overall survival of this class of patients.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum Tolerated Dose
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.
Every Cycle-28 days
David O'Malley, MD
Ohio State University
United States: Food and Drug Administration
|OSU Gyn Oncology at Mill Run||Hilliard, Ohio 43026|