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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00390611
Recruitment Status : Completed
First Posted : October 20, 2006
Results First Posted : December 22, 2014
Last Update Posted : December 22, 2014
Information provided by (Responsible Party):
SCRI Development Innovations, LLC

October 19, 2006
October 20, 2006
December 12, 2014
December 22, 2014
December 22, 2014
October 2006
July 2012   (Final data collection date for primary outcome measure)
2-year Progression-free Survival [ Time Frame: 2 years ]
The proportion of patients with progression-free survival at 2 years. Progression-free survival is measured from Day 1 of study drug administration to disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death on study. Progression is defined in RECIST v1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
progression free survival
Complete list of historical versions of study NCT00390611 on Archive Site
  • Overall Response Rate (ORR) [ Time Frame: 18 months ]
    Number of patients with either complete response (CR) or partial response (PR) as defined in Response Evaluation Criteria in Solid Tumors (for patients with measurable disease) or determined by CA-125 levels (for patients without measurable disease). Complete Response: Disappearance of all target lesions, disappearance of all non-target lesions, and normalization of CA-125 for at least 4 weeks. In patients who have only elevated CA-125, the CA-125 must normalize (< 23U/mL) for more than 4 weeks. Partial Response: At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters. For patients with elevated CA-125 only, partial response will be defined as a > 50% decrease in the serum CA-125 level.
  • Overall Survival (OS) [ Time Frame: 18 months ]
    Overall survival was measured from the date of study entry until the date of death
  • Toxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/Sorafenib [ Time Frame: 18 months ]
    Number of patients experiencing treatment-related adverse events
  • objective response
  • overall survival
  • toxicity
Not Provided
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Paclitaxel and Carboplatin With Or Without Sorafenib In The First-Line Treatment Of Patients With Ovarian Cancer
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
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.

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

Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Ovarian Cancer
  • Drug: Sorafenib
    Other Name: BAY 43-9006
  • Drug: Paclitaxel
  • Drug: Carboplatin
  • Active Comparator: Paclitaxel/Carboplatin/Sorafenib
    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
    • Drug: Sorafenib
    • Drug: Paclitaxel
    • Drug: Carboplatin
  • Active Comparator: Paclitaxel/carboplatin
    Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV
    • Drug: Paclitaxel
    • Drug: Carboplatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
April 2014
July 2012   (Final data collection date for primary outcome measure)

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


    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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
SCRI Development Innovations, LLC
SCRI Development Innovations, LLC
Principal Investigator: John D. Hainsworth, MD SCRI Development Innovations, LLC
SCRI Development Innovations, LLC
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP