High-dose Bevacizumab in Advanced Renal Carcinoma Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT00455975
First received: April 3, 2007
Last updated: February 13, 2014
Last verified: February 2014
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by SCRI Development Innovations, LLC:

Primary Outcome Measures:
  • progression-free survival [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • overall survival [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • objective response rate [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • overall tolerability and toxicity of high-dose bevacizumab [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    the treatment of patients with renal cell carcinoma


Estimated Enrollment: 120
Study Start Date: February 2007
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
pts 61-120 receive weekly avastin
Bevacizumab 15mg/kg IV weekly until progressive disease or toxicity
Drug: Bevacizumab
Bevacizumab
Other Name: Avastin
1st 60 pts receive Bi-weekly Avastin
Bevacizumab 15mg/kg IV every 2 weeks until progressive disease or toxicity
Drug: Bevacizumab
Bevacizumab
Other Name: Avastin

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 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
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
Investigators
Study Chair: John D. Hainsworth, M.D. SCRI Development Innovations, LLC
  More Information

No publications provided

Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT00455975     History of Changes
Other Study ID Numbers: SCRI GU 43, AVF 3913s
Study First Received: April 3, 2007
Last Updated: February 13, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by SCRI Development Innovations, LLC:
Kidney Cancer
Renal Cancer
Clear Cell Carcinoma

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

ClinicalTrials.gov processed this record on July 22, 2014