Intraperitoneal Paclitaxel and Carboplatin With IV Avastin Therapy in Patients With Carcinomas of Mullerian Origin
Summary
The goal of this clinical research study is to learn about the safety and tolerability of paclitaxel and carboplatin when given in combination with Avastin to patients with ovarian, primary peritoneal, or fallopian tube cancer. Objectives: Primary study goals: To investigate the safety and tolerability of carboplatin and paclitaxel administered IP in combination with IV Avastin To determine if Avastin influences the pharmacokinetics of IP administered chemotherapeutic agents Secondary study goals: To determine the systemic exposure to paclitaxel and carboplatin during initial and late cycles of IP dosing. To collect overall survival (OS) and progression-free survival (PFS) To determine changes in IP VEGF levels To determine site of first recurrence Information on CA-125 response and clinical response will be descriptive as secondary goals of this study Exploratory goal: To estimate proportion of patients completing entire course of treatment
Timeline
- Start
- 2008-02
- Primary completion
- 2009-08
- Completion
- 2021-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | 15 mg/kg | Intravenous |
| Subject | Carboplatin | Small molecule | 6 unknown | Intravenous |
| Subject | Paclitaxel | Small molecule | 60 mg/m2 | Intravenous |