High-dose Bevacizumab in Advanced Renal Carcinoma Patients
Phase II Trial of High-Dose Bevacizumab in the Treatment of Patients With Advanced Clear Cell Renal Carcinoma
2 other identifiers
interventional
119
1 country
13
Brief Summary
This trial will examine the effectiveness and the side effects of 2 higher dosing schedules of bevacizumab in patients that have advanced clear cell renal carcinoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Feb 2007
Longer than P75 for phase_2
13 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
February 1, 2007
CompletedFirst Submitted
Initial submission to the registry
April 3, 2007
CompletedFirst Posted
Study publicly available on registry
April 4, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedResults Posted
Study results publicly available
December 22, 2014
CompletedDecember 22, 2014
December 1, 2014
6.4 years
April 3, 2007
December 12, 2014
December 12, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free Survival
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
18 months (expected)
Secondary Outcomes (3)
Overall Survival (OS)
18 months
Objective Response Rate
18 months
Overall Tolerability and Toxicity of High-dose Bevacizumab
18 months
Study Arms (2)
Weekly Avastin
EXPERIMENTALBevacizumab 15mg/kg IV weekly until progressive disease or toxicity
Bi-weekly Avastin
EXPERIMENTALBevacizumab 15mg/kg IV every 2 weeks until progressive disease or toxicity
Interventions
Eligibility Criteria
You may qualify if:
- Histologically documented metastatic or unresectable locally recurrent clear cell renal carcinoma
- Previous kidney removal is required except if the primary tumor was smaller than 5 cm or there was extensive liver or bone metastasis
- Patients may have received a maximum of 1 prior systemic treatment of immunotherapy (Interferon, IL-2), chemotherapy, or combination chemo+immunotherapy for metastatic disease.
- No prior bevacizumab
- Measurable disease
- Adequate liver and kidney function
- Age 18 and older
You may not qualify if:
- Acute MI within the past 6 months
- Uncontrolled high blood pressure or history of hypertensive crisis
- Clinically significant cardiovascular disease
- Active brain cancer
- Meningeal metastasis
- Pregnant or lactating women
- Prior treatment for another cancer less than 5 years ago
- No diseases of the central nervous system (eg. uncontrolled seizures, strokes or TIAs
- No bleeding from the mouth, rectum or coughing up blood or history of other bleeding or clotting disorders
- No history of deep vein thrombosis less than 12 months ago or are currently requiring full dose anticoagulation
- No major surgical procedures, open biopsies or traumatic injury in past 28 days
- No patients with peg tubes or feeding tubes
- No patients with non healing wounds, ulcers or long bone fractures
- No history of abdominal fistulas, gastrointestinal perforation or intrabdominal abscess within 6 months
- No symptomatic peripheral vascular disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SCRI Development Innovations, LLClead
- Genentech, Inc.collaborator
Study Sites (13)
Florida Cancer Specialists
Fort Myers, Florida, 33901, United States
Northeast Georgia Medical Center
Gainesville, Georgia, 30501, United States
Consultants in Blood Disorders and Cancer
Louisville, Kentucky, 40207, United States
Center for Cancer and Blood Disorders
Bethesda, Maryland, 20817, United States
Methodist Cancer Center
Omaha, Nebraska, 68114, United States
Cancer Care of Western North Carolina
Asheville, North Carolina, 28801, United States
Oncology Hematology Care
Cincinnati, Ohio, 45242, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Spartanburg Regional Medical Center
Spartanburg, South Carolina, 29303, United States
Chattanooga Oncology Hematology Associates
Chattanooga, Tennessee, 37404, United States
Family Cancer Center
Collierville, Tennessee, 38017, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, 37023, United States
Peninsula Cancer Institute
Newport News, Virginia, 23601, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- John Hainsworth MD
- Organization
- Sarah Cannon Research Institute
Study Officials
- STUDY CHAIR
John D. Hainsworth, M.D.
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
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 3, 2007
First Posted
April 4, 2007
Study Start
February 1, 2007
Primary Completion
July 1, 2013
Study Completion
September 1, 2013
Last Updated
December 22, 2014
Results First Posted
December 22, 2014
Record last verified: 2014-12