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

Brief 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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: Sorafenib Drug: Paclitaxel Drug: Carboplatin Phase 2

Detailed Description:

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2006
Actual Primary Completion Date : July 2012
Actual Study Completion Date : April 2014

Arm Intervention/treatment
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
Other Name: BAY 43-9006
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

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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.

  2. Overall Survival (OS) [ Time Frame: 18 months ]
    Overall survival was measured from the date of study entry until the date of death

  3. Toxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/Sorafenib [ Time Frame: 18 months ]
    Number of patients experiencing treatment-related adverse events

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00390611

United States, Arkansas
Northeast Arkansas Clinic
Jonesboro, Arkansas, United States, 72401
United States, Florida
Florida Cancer Specialists
Fort Myers, Florida, United States, 33901
Holy Cross Hospital
Ft. Lauderdale, Florida, United States, 33308
Gulfcoast Oncology Associates
St. Petersburg, Florida, United States, 33705
United States, Georgia
Medical College of Georgia Cancer Specialists
Augusta, Georgia, United States, 30912
United States, Indiana
Providence Medical Group
Terre Haute, Indiana, United States, 47802
United States, Maryland
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States, 20817
National Capital Clinical Research Consortium
Bethesda, Maryland, United States, 20817
United States, Michigan
St. Joseph Mercy Hospital
Ann Arbor, Michigan, United States, 48106
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, United States, 49503
United States, Ohio
Oncology Hematology Care
Cincinnati, Ohio, United States, 45242
United States, Oklahoma
University of Oklahoma
Oklahoma City, Oklahoma, United States, 73104
United States, South Carolina
South Carolina Oncology Associates, PA
Columbia, South Carolina, United States, 29210
United States, Tennessee
Tennessee Valley Clinical Research
Chattanooga, Tennessee, United States, 37411
Family Cancer Center
Collierville, Tennessee, United States, 38017
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37023
United States, Virginia
Peninsula Cancer Center
Newport News, Virginia, United States, 23601
Sponsors and Collaborators
SCRI Development Innovations, LLC
Principal Investigator: John D. Hainsworth, MD SCRI Development Innovations, LLC

Responsible Party: SCRI Development Innovations, LLC Identifier: NCT00390611     History of Changes
Other Study ID Numbers: SCRI GYN 19
First Posted: October 20, 2006    Key Record Dates
Results First Posted: December 22, 2014
Last Update Posted: December 22, 2014
Last Verified: December 2014

Keywords provided by SCRI Development Innovations, LLC:
Ovarian Cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs