High-dose Bevacizumab in Advanced Renal Carcinoma Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Phase II Trial of High-Dose Bevacizumab in the Treatment of Patients With Advanced Clear Cell Renal Carcinoma

Conditions
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Renal Cancer, Kidney Cancer

Intervention / Treatment
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* Drug: Bevacizumab


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Weekly Avastin<br>Bevacizumab 15mg/kg IV weekly until progressive disease or toxicity | Drug: Bevacizumab<br>* Bevacizumab<br>* Other names: Avastin;|
| Experimental: Bi-weekly Avastin<br>Bevacizumab 15mg/kg IV every 2 weeks until progressive disease or toxicity | Drug: Bevacizumab<br>* Bevacizumab<br>* Other names: Avastin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) | Measured from date of study entry to date of death due to any cause. | 18 months | 
| Objective Response Rate | The number of patients with observed complete response [CR] or partial response [PR]. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR | 18 months | 
| Overall Tolerability and Toxicity of High-dose Bevacizumab | Number of patients treated with high-dose bevacizumab experiencing Grade 3/4, treatment-related toxicities | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kidney Cancer, Renal Cancer, Clear Cell Carcinoma