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A Randomized Phase II Study of Paclitaxel/Carboplatin With or Without Sorafenib in the First-Line Treatment of Patients With Stage III/IV Epithelial Ovarian Cancer

Phase 2
18 Years
Open (Enrolling)
Ovarian Cancer

Thank you

Trial Information

A Randomized Phase II Study of Paclitaxel/Carboplatin With or Without Sorafenib in the First-Line Treatment of Patients With Stage III/IV Epithelial Ovarian Cancer

All patients must be at least 4 weeks from cytoreductive surgery before starting treatment.
Patients will be randomized to receive treatment with either paclitaxel/carboplatin +
sorafenib or paclitaxel/carboplatin. Paclitaxel/carboplatin will be repeated every 21 days
for a maximum of 6 cycles. Patients with objective response/stable disease after completing
6 courses of chemotherapy will continue sorafenib until disease progression or for a total
of 12 months.

- Regimen A: Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over
20 minutes IV, Day 1 Sorafenib 400mg PO bid

- Regimen B: Paclitaxel 175mg/m2, 1-3 hour IV infusion, Day 1 Carboplatin AUC 6.0, 20 minute
IV infusion, Day 1

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

progression free survival

Outcome Time Frame:

18 months

Safety Issue:


Principal Investigator

John D. Hainsworth, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sarah Cannon Research Institute


United States: Institutional Review Board

Study ID:




Start Date:

October 2006

Completion Date:

July 2013

Related Keywords:

  • Ovarian Cancer
  • Ovarian Cancer
  • Ovarian Neoplasms



Northeast Arkansas Clinic Jonesboro, Arkansas  72401-3125
Florida Cancer Specialists Fort Myers, Florida  33901
South Carolina Oncology Associates, PA Columbia, South Carolina  29210
Family Cancer Center Collierville, Tennessee  38017
Center for Cancer and Blood Disorders Bethesda, Maryland  20817
Clearview Cancer Institute Huntsville, Alabama  35805
Grand Rapids Clinical Oncology Program Grand Rapids, Michigan  49503
Gulfcoast Oncology Associates St. Petersburg, Florida  33705
Tennessee Oncology, PLLC Clarksville, Tennessee  37043
Oncology Hematology Care Cincinnati, Ohio  45242
Providence Medical Group Terre Haute, Indiana  47802
Medical College of Georgia Cancer Specialists Augusta, Georgia  30912