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

This study has been completed.
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT00390611
First received: October 19, 2006
Last updated: September 26, 2014
Last verified: September 2014
  Purpose

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 Intervention Phase
Ovarian Cancer
Drug: Sorafenib
Drug: Paclitaxel
Drug: Carboplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by SCRI Development Innovations, LLC:

Primary Outcome Measures:
  • progression free survival [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Enrollment: 85
Study Start Date: October 2006
Study Completion Date: April 2014
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Paclitaxel
Drug: Carboplatin
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
Paclitaxel
Drug: Carboplatin
Carboplatin

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00390611

Locations
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
Bayer
Investigators
Principal Investigator: John D. Hainsworth, MD SCRI Development Innovations, LLC
  More Information

No publications provided

Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT00390611     History of Changes
Other Study ID Numbers: SCRI GYN 19, SR05-918
Study First Received: October 19, 2006
Last Updated: September 26, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by SCRI Development Innovations, LLC:
Ovarian Cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Adnexal Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Urogenital Neoplasms
Carboplatin
Paclitaxel
Sorafenib
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 23, 2014