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
2 other identifiers
interventional
85
1 country
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 ovarian-cancer
Started Oct 2006
Longer than P75 for phase_2 ovarian-cancer
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
October 19, 2006
CompletedFirst Posted
Study publicly available on registry
October 20, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedResults Posted
Study results publicly available
December 22, 2014
CompletedDecember 22, 2014
December 1, 2014
5.8 years
October 19, 2006
December 12, 2014
December 12, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
2-year Progression-free Survival
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
2 years
Secondary Outcomes (3)
Overall Response Rate (ORR)
18 months
Overall Survival (OS)
18 months
Toxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/Sorafenib
18 months
Study Arms (2)
Paclitaxel/Carboplatin/Sorafenib
ACTIVE COMPARATORPaclitaxel 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
ACTIVE COMPARATORPaclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV
Interventions
Eligibility Criteria
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
- +9 more criteria
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
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SCRI Development Innovations, LLClead
- Bayercollaborator
Study Sites (17)
Northeast Arkansas Clinic
Jonesboro, Arkansas, 72401, United States
Holy Cross Hospital
Fort Lauderdale, Florida, 33308, United States
Florida Cancer Specialists
Fort Myers, Florida, 33901, United States
Gulfcoast Oncology Associates
St. Petersburg, Florida, 33705, United States
Medical College of Georgia Cancer Specialists
Augusta, Georgia, 30912, United States
Providence Medical Group
Terre Haute, Indiana, 47802, United States
Center for Cancer and Blood Disorders
Bethesda, Maryland, 20817, United States
National Capital Clinical Research Consortium
Bethesda, Maryland, 20817, United States
St. Joseph Mercy Hospital
Ann Arbor, Michigan, 48106, United States
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, 49503, United States
Oncology Hematology Care
Cincinnati, Ohio, 45242, United States
University of Oklahoma
Oklahoma City, Oklahoma, 73104, United States
South Carolina Oncology Associates, PA
Columbia, South Carolina, 29210, United States
Tennessee Valley Clinical Research
Chattanooga, Tennessee, 37411, United States
Family Cancer Center
Collierville, Tennessee, 38017, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, 37023, United States
Peninsula Cancer Center
Newport News, Virginia, 23601, United States
Related Publications (1)
Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.
PMID: 37185961DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- John D. Hainsworth, MD
- Organization
- Sarah Cannon Research Institute
Study Officials
- PRINCIPAL INVESTIGATOR
John D. Hainsworth, MD
SCRI Development Innovations, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 19, 2006
First Posted
October 20, 2006
Study Start
October 1, 2006
Primary Completion
July 1, 2012
Study Completion
April 1, 2014
Last Updated
December 22, 2014
Results First Posted
December 22, 2014
Record last verified: 2014-12