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

Phase 2
18 Years
Open (Enrolling)
Renal Cancer, Kidney Cancer

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Trial Information

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

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.

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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

progression-free survival

Outcome Time Frame:

18 months

Safety Issue:


Principal Investigator

John D. Hainsworth, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Sarah Cannon Research Institute


United States: Food and Drug Administration

Study ID:




Start Date:

February 2007

Completion Date:

December 2013

Related Keywords:

  • Renal Cancer
  • Kidney Cancer
  • Kidney Cancer
  • Renal Cancer
  • Clear Cell Carcinoma
  • Carcinoma
  • Carcinoma, Renal Cell
  • Kidney Neoplasms



Florida Cancer Specialists Fort Myers, Florida  33901
University of Pittsburgh Medical Center Pittsburgh, Pennsylvania  15213
Northeast Georgia Medical Center Gainesville, Georgia  30501
Spartanburg Regional Medical Center Spartanburg, South Carolina  29303
Consultants in Blood Disorders and Cancer Louisville, Kentucky  40207
Family Cancer Center Collierville, Tennessee  38017
Methodist Cancer Center Omaha, Nebraska  68114
Peninsula Cancer Institute Newport News, Virginia  23601
Center for Cancer and Blood Disorders Bethesda, Maryland  20817
Cancer Care of Western North Carolina Asheville, North Carolina  28801
Tennessee Oncology, PLLC Clarksville, Tennessee  37043
Oncology Hematology Care Cincinnati, Ohio  45242
Chattanooga Oncology Hematology Associates Chattanooga, Tennessee  37404