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High-Dose Bevacizumab in Advanced Renal Carcinoma Patients
This study is currently recruiting participants.
Verified by Sarah Cannon Research Institute, May 2009
First Received: April 3, 2007   Last Updated: May 6, 2009   History of Changes
Sponsors and Collaborators: Sarah Cannon Research Institute
SCRI Oncology Research Consortium
Genentech
Information provided by: Sarah Cannon Research Institute
ClinicalTrials.gov Identifier: NCT00455975
  Purpose

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 Intervention Phase
Renal Cancer
Kidney Cancer
Drug: Bevacizumab
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title: Phase II Trial of High-Dose Bevacizumab in the Treatment of Patients With Advanced Clear Cell Renal Carcinoma

Resource links provided by NLM:


Further study details as provided by Sarah Cannon Research Institute:

Primary Outcome Measures:
  • Effectiveness of the treatment will be measured by periodic tests/scans [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Side effects of treatment will be evaluated at each patient visit [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Define overall tolerability and toxicity of the high-dose bevacizumab regimen [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: February 2007
Estimated Study Completion Date: February 2010
Estimated Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Bevacizumab
    Bevacizumab
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 intraabdominal 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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00455975

Contacts
Contact: John D. Hainsworth, M.D. 615-329-7274 jhainsworth@tnonc.com
Contact: Trials Info 615-329-7274 trialsinfo@scresearch.net

Locations
United States, Georgia
Northeast Georgia Medical Center Recruiting
Gainesville, Georgia, United States, 30501
United States, Kentucky
Consultants in Blood Disorders and Cancer Recruiting
Louisville, Kentucky, United States, 40207
Contact: Judy Sisk     502-897-1166 ext 129     jsisk@cbcdocs.com    
United States, Maryland
Center for Cancer and Blood Disorders Recruiting
Bethesda, Maryland, United States, 20817
United States, Nebraska
Methodist Cancer Center Recruiting
Omaha, Nebraska, United States, 68114
United States, North Carolina
Cancer Care of Western North Carolina Recruiting
Asheville, North Carolina, United States, 28801
United States, Ohio
Aultman Hospital Recruiting
Canton, Ohio, United States, 44710
Oncology Hematology Care Recruiting
Cincinnati, Ohio, United States, 45242
Contact: Research Program Coordinator     513-891-4800     contact@ohcmail.com    
United States, South Carolina
Spartanburg Regional Medical Center Recruiting
Spartanburg, South Carolina, United States, 29303
Contact: Nancy Sprouse     864-560-6016     nsprouse@srhs.com    
United States, Tennessee
Chattanooga Oncology Hematology Associates Recruiting
Chattanooga, Tennessee, United States, 37404
Contact: Research Coordiantor     423-698-1844     research@cohaonline.com    
Tennessee Oncology, PLLC Recruiting
Nashville, Tennessee, United States, 37023
Associates in Hematology Oncology Recruiting
Chattanooga, Tennessee, United States, 37404
Family Cancer Center Recruiting
Collierville, Tennessee, United States, 38017
United States, Virginia
Peninsula Cancer Institute Recruiting
Newport News, Virginia, United States, 23601
Sponsors and Collaborators
Sarah Cannon Research Institute
SCRI Oncology Research Consortium
Genentech
Investigators
Study Chair: John D. Hainsworth, M.D. SCRI Oncology Research Consortium
  More Information

No publications provided

Responsible Party: SCRI Oncology Research Consortium ( John D. Hainsworth, M.D. )
Study ID Numbers: SCRI GU 43, AVF 3913s
Study First Received: April 3, 2007
Last Updated: May 6, 2009
ClinicalTrials.gov Identifier: NCT00455975     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Sarah Cannon Research Institute:
Kidney Cancer
Renal Cancer
Clear Cell Carcinoma

Study placed in the following topic categories:
Urinary Tract Neoplasm
Kidney Cancer
Urogenital Neoplasms
Bevacizumab
Urologic Neoplasms
Angiogenesis Inhibitors
Carcinoma
Adenocarcinoma, Clear Cell
Renal Cancer
Urologic Diseases
Kidney Neoplasms
Carcinoma, Renal Cell
Clear Cell Renal Cell Carcinoma
Kidney Diseases
Adenocarcinoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Urogenital Neoplasms
Bevacizumab
Urologic Neoplasms
Angiogenesis Inhibitors
Pharmacologic Actions
Carcinoma
Neoplasms
Neoplasms by Site
Urologic Diseases
Kidney Neoplasms
Therapeutic Uses
Carcinoma, Renal Cell
Growth Inhibitors
Angiogenesis Modulating Agents
Kidney Diseases
Adenocarcinoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 10, 2009