This trial is active, not recruiting.

Conditions renal cancer, kidney cancer
Treatment bevacizumab
Phase phase 2
Target VEGF
Sponsor SCRI Development Innovations, LLC
Collaborator Genentech
Start date February 2007
End date July 2014
Trial size 120 participants
Trial identifier NCT00455975, AVF 3913s, SCRI GU 43


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Bevacizumab 15mg/kg IV weekly until progressive disease or toxicity
bevacizumab Avastin
Bevacizumab 15mg/kg IV every 2 weeks until progressive disease or toxicity
bevacizumab Avastin

Primary Outcomes

progression-free survival
time frame: 18 months

Secondary Outcomes

overall survival
time frame: 18 months
objective response rate
time frame: 18 months
overall tolerability and toxicity of high-dose bevacizumab
time frame: 18 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - 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 Exclusion Criteria: - 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 Please note: there are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have. You can then decide if you wish to participate.

Additional Information

Official title Phase II Trial of High-Dose Bevacizumab in the Treatment of Patients With Advanced Clear Cell Renal Carcinoma
Description Bevacizumab is considered a targeted drug. Targeted drugs act on specific receptors on a cell. Bevacizumab blocks receptors that help cancer cells develop blood supplies so that the cancer can grow. These specific receptors are found in greater numbers in kidney cancer. In that regard bevacizumab will be tested in 2 doses that are higher than non-kidney cancer treatments with bevacizumab. One group of patients will receive bevacizumab at 15 mg per kg by vein every 2 weeks. A total of 75 patients will be treated with this dose. If this dose is well tolerated a second group of patients will receive bevacizumab at 15mg per kg by vein weekly.
Trial information was received from ClinicalTrials.gov and was last updated in February 2014.
Information provided to ClinicalTrials.gov by SCRI Development Innovations, LLC.