Paclitaxel and Carboplatin With Or Without Sorafenib In The First-Line Treatment Of Patients With Ovarian Cancer

Exclusion Criteria

• •1. Age \< 18 years
• •2. Active cardiac disease, including: A) congestive heart failure \> class II
• •NYHA , B) unstable angina or onset of angina within last 3 months, C) myocardial infarction within 6 months
• •3. Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
• •4. Patients with CNS metastases. Patients with neurological symptoms
• •must undergo a CT scan/MRI of the brain to exclude brain metastasis.
• •5. Uncontrolled hypertension defined as systolic blood pressure \> 150mmHg or diastolic pressure \> 90mmHg, despite optimal medical management
• •6. Known HIV, chronic hepatitis B or chronic hepatitis C infections
• •7. Women who are pregnant or lactating. Women of childbearing potential
• •must agree to use adequate contraception from time of study entry until
• •at least 3 months after the last administration of study drug.
• •8. Active clinically serious infection (\> grade 2)
• •9. Thrombotic or embolic events such as cerebral vascular accident
• •including transient ischemic attacks within the last 6 months.
• •10. Pulmonary hemorrhage/bleeding event ≥ grade 2 within 4 weeks of
• •starting treatment.
• •11. Any other hemorrhage/bleeding event ≥ grade 3 within 4 weeks of
• •starting treatment
• •12. Serious non-healing wound, ulcer, or bone fracture
• •13. Evidence of history of bleeding diathesis or coagulopathy
• •14. Major surgery, open biopsy, or significant traumatic injury within 4 weeks
• •of starting treatment.
• •15. Any condition that impairs the ability to swallow whole pills
• •16. Patients with any type of malabsorption
• •17. Known or suspected allergy to any of the agents used in this treatment
• •18. Use of St. John's Wort or rifampin