Paclitaxel and Carboplatin With Or Without Sorafenib In The First-Line Treatment Of Patients With Ovarian Cancer
Condition: Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Intervention: Sorafenib; Paclitaxel; Carboplatin
Intervention description: Paclitaxel; Carboplatin
Intervention MeSH terms: Paclitaxel; Carboplatin; Sorafenib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 85.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ovarian Cancer

Summary:

      This trial will compare the efficacy and toxicity of standard first-line chemotherapy alone
      vs. standard chemotherapy plus sorafenib in patients with stage III/IV ovarian cancer
      following cytoreductive surgery. Patients with residual large volume disease and/or bowel
      involvement will be excluded, to minimize the risk of bowel perforation.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Histologically confirmed, stage III or IV epithelial ovarian carcinoma

          2. No previous treatment with chemotherapy or radiation therapy

          3. All patients must have undergone cytoreductive surgery, with the

             following results:

               1. No residual tumor nodule > 3cm

               2. No residual tumor involvement of the bowel (ie. invasion into bowel

                  wall)

               3. No residual intestinal obstruction

          4. Measurable or evaluable disease. Patients with elevated CA-125 levels

             and/or evaluable disease per RECIST criteria are eligible.

          5. ECOG performance status 0 or 1.

          6. ANC ≥ 1500/µL, platelets ≥ 100,000/µL, hemoglobin ≥ 9.0 g/dL.

          7. Total bilirubin ≤ 1.5 x upper limits of normal (ULN), ALT and AST ≤ 2.5 x

             ULN (≤ 5 x ULN for patients with liver metastases)

          8. Serum creatinine _ 1.5 x ULN

          9. INR < 1.5 or a PT/PTT within normal limits. Patients receiving anticoagulation

             treatment with an agent such as warfarin or heparin may be

             allowed to participate. For patients on warfarin, the INR may be > 1.5,

             and should be measured prior to initiation of sorafenib and monitored at

             least weekly until INR is stable in the desired therapeutic range.

         10. Women of childbearing potential must have a negative serum pregnancy

             test performed within 7 days prior to start of treatment.

         11. Patients must be able to understand the nature of this study and give

        written informed consent.

        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