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

Completed · Phase 2

Conditions studied: Ovarian Cancer

In brief

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.

Key facts

Study ID

NCT00390611

Run by

SCRI Development Innovations, LLC

People needed

85

Starts

2006-10-01

Expected to finish

2014-04-01

Last updated by the study team

2014-12-22

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed, stage III or IV epithelial ovarian carcinoma
• No previous treatment with chemotherapy or radiation therapy
• All patients must have undergone cytoreductive surgery, with the
• following results:
• No residual tumor nodule > 3cm
• No residual tumor involvement of the bowel (ie. invasion into bowel
• wall)
• No residual intestinal obstruction
• Measurable or evaluable disease. Patients with elevated CA-125 levels
• and/or evaluable disease per RECIST criteria are eligible.
• ECOG performance status 0 or 1.
• ANC ≥ 1500/µL, platelets ≥ 100,000/µL, hemoglobin ≥ 9.0 g/dL.
• 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)
• Serum creatinine _ 1.5 x ULN
• 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.
• Women of childbearing potential must have a negative serum pregnancy
• test performed within 7 days prior to start of treatment.
• Patients must be able to understand the nature of this study and give
• written informed consent.

You may not qualify if…

• Age < 18 years
• 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
• Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
• Patients with CNS metastases. Patients with neurological symptoms
• must undergo a CT scan/MRI of the brain to exclude brain metastasis.
• Uncontrolled hypertension defined as systolic blood pressure > 150mmHg or diastolic pressure > 90mmHg, despite optimal medical management
• Known HIV, chronic hepatitis B or chronic hepatitis C infections
• 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.
• Active clinically serious infection (> grade 2)
• Thrombotic or embolic events such as cerebral vascular accident
• including transient ischemic attacks within the last 6 months.
• Pulmonary hemorrhage/bleeding event ≥ grade 2 within 4 weeks of
• starting treatment.
• Any other hemorrhage/bleeding event ≥ grade 3 within 4 weeks of
• starting treatment
• Serious non-healing wound, ulcer, or bone fracture
• Evidence of history of bleeding diathesis or coagulopathy
• Major surgery, open biopsy, or significant traumatic injury within 4 weeks
• of starting treatment.
• Any condition that impairs the ability to swallow whole pills
• Patients with any type of malabsorption
• Known or suspected allergy to any of the agents used in this treatment

Where it is running

• Northeast Arkansas Clinic — Jonesboro, Arkansas, United States
• Holy Cross Hospital — Fort Lauderdale, Florida, United States
• Florida Cancer Specialists — Fort Myers, Florida, United States
• Gulfcoast Oncology Associates — St. Petersburg, Florida, United States
• Medical College of Georgia Cancer Specialists — Augusta, Georgia, United States
• Providence Medical Group — Terre Haute, Indiana, United States
• Center for Cancer and Blood Disorders — Bethesda, Maryland, United States
• National Capital Clinical Research Consortium — Bethesda, Maryland, United States
• St. Joseph Mercy Hospital — Ann Arbor, Michigan, United States
• Grand Rapids Clinical Oncology Program — Grand Rapids, Michigan, United States
• Oncology Hematology Care — Cincinnati, Ohio, United States
• University of Oklahoma — Oklahoma City, Oklahoma, United States
• South Carolina Oncology Associates, PA — Columbia, South Carolina, United States
• Tennessee Valley Clinical Research — Chattanooga, Tennessee, United States
• Family Cancer Center — Collierville, Tennessee, United States
• Tennessee Oncology, PLLC — Nashville, Tennessee, United States
• Peninsula Cancer Center — Newport News, Virginia, United States

Full record on ClinicalTrials.gov

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