Paclitaxel and Carboplatin With Or Without Sorafenib In The First-Line Treatment Of Patients With Ovarian Cancer
- Conditions
- Ovarian Cancer
- Interventions
- Registration Number
- NCT00390611
- Lead Sponsor
- 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.
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 85
-
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.
-
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
-
Use of St. John's Wort or rifampin
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Paclitaxel/carboplatin Carboplatin Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV Paclitaxel/Carboplatin/Sorafenib 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 Paclitaxel/Carboplatin/Sorafenib Paclitaxel 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 Paclitaxel/Carboplatin/Sorafenib Carboplatin 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 Paclitaxel/carboplatin Paclitaxel Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV
- Primary Outcome Measures
Name Time Method 2-year Progression-free Survival 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
Name Time Method Overall Survival (OS) 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 18 months Number of patients experiencing treatment-related adverse events
Overall Response Rate (ORR) 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.
Trial Locations
- Locations (17)
Northeast Arkansas Clinic
🇺🇸Jonesboro, Arkansas, United States
Florida Cancer Specialists
🇺🇸Fort Myers, Florida, United States
Holy Cross Hospital
🇺🇸Ft. Lauderdale, Florida, United States
Medical College of Georgia Cancer Specialists
🇺🇸Augusta, Georgia, United States
Gulfcoast Oncology Associates
🇺🇸St. Petersburg, Florida, United States
Providence Medical Group
🇺🇸Terre Haute, Indiana, United States
St. Joseph Mercy Hospital
🇺🇸Ann Arbor, Michigan, United States
Grand Rapids Clinical Oncology Program
🇺🇸Grand Rapids, Michigan, 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
Peninsula Cancer Center
🇺🇸Newport News, Virginia, United States
Oncology Hematology Care
🇺🇸Cincinnati, Ohio, United States
University of Oklahoma
🇺🇸Oklahoma City, Oklahoma, United States
Tennessee Oncology, PLLC
🇺🇸Nashville, Tennessee, United States
Center for Cancer and Blood Disorders
🇺🇸Bethesda, Maryland, United States
National Capital Clinical Research Consortium
🇺🇸Bethesda, Maryland, United States