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High-dose Bevacizumab in Advanced Renal Carcinoma Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00455975
Recruitment Status : Completed
First Posted : April 4, 2007
Results First Posted : December 22, 2014
Last Update Posted : December 22, 2014
Genentech, Inc.
Information provided by (Responsible Party):
SCRI Development Innovations, LLC

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.

Condition or disease Intervention/treatment Phase
Renal Cancer Kidney Cancer Drug: Bevacizumab Phase 2

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 119 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of High-Dose Bevacizumab in the Treatment of Patients With Advanced Clear Cell Renal Carcinoma
Study Start Date : February 2007
Actual Primary Completion Date : July 2013
Actual Study Completion Date : September 2013

Arm Intervention/treatment
Experimental: Weekly Avastin
Bevacizumab 15mg/kg IV weekly until progressive disease or toxicity
Drug: Bevacizumab
Other Name: Avastin

Experimental: Bi-weekly Avastin
Bevacizumab 15mg/kg IV every 2 weeks until progressive disease or toxicity
Drug: Bevacizumab
Other Name: Avastin

Primary Outcome Measures :
  1. Progression-free Survival [ Time Frame: 18 months (expected) ]
    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 :
  1. Overall Survival (OS) [ Time Frame: 18 months ]
    Measured from date of study entry to date of death due to any cause.

  2. Objective Response Rate [ Time Frame: 18 months ]
    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

  3. Overall Tolerability and Toxicity of High-dose Bevacizumab [ Time Frame: 18 months ]
    Number of patients treated with high-dose bevacizumab experiencing Grade 3/4, treatment-related toxicities

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00455975

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United States, Florida
Florida Cancer Specialists
Fort Myers, Florida, United States, 33901
United States, Georgia
Northeast Georgia Medical Center
Gainesville, Georgia, United States, 30501
United States, Kentucky
Consultants in Blood Disorders and Cancer
Louisville, Kentucky, United States, 40207
United States, Maryland
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States, 20817
United States, Nebraska
Methodist Cancer Center
Omaha, Nebraska, United States, 68114
United States, North Carolina
Cancer Care of Western North Carolina
Asheville, North Carolina, United States, 28801
United States, Ohio
Oncology Hematology Care
Cincinnati, Ohio, United States, 45242
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303
United States, Tennessee
Chattanooga Oncology Hematology Associates
Chattanooga, Tennessee, United States, 37404
Family Cancer Center
Collierville, Tennessee, United States, 38017
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37023
United States, Virginia
Peninsula Cancer Institute
Newport News, Virginia, United States, 23601
Sponsors and Collaborators
SCRI Development Innovations, LLC
Genentech, Inc.
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Study Chair: John D. Hainsworth, M.D. SCRI Development Innovations, LLC

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Responsible Party: SCRI Development Innovations, LLC Identifier: NCT00455975     History of Changes
Other Study ID Numbers: SCRI GU 43
AVF 3913s
First Posted: April 4, 2007    Key Record Dates
Results First Posted: December 22, 2014
Last Update Posted: December 22, 2014
Last Verified: December 2014
Keywords provided by SCRI Development Innovations, LLC:
Kidney Cancer
Renal Cancer
Clear Cell Carcinoma
Additional relevant MeSH terms:
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Kidney Neoplasms
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors