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Bevacizumab (Avastin) and RAD001(Everolimus)in the Treatment of Advanced Clear Cell Renal Carcinoma

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: NCT00323739
Recruitment Status : Completed
First Posted : May 9, 2006
Results First Posted : March 6, 2013
Last Update Posted : July 26, 2013
Genentech, Inc.
Information provided by (Responsible Party):
SCRI Development Innovations, LLC

Brief Summary:
This phase II trial will evaluate the combination of bevacizumab + RAD001 in patients with metastatic renal cell carcinoma. In this trial the investigators will evaluate this combination in patients previously untreated with any anti-angiogenesis agent and patients who have previously received one prior regimen containing an anti-angiogenesis agent.

Condition or disease Intervention/treatment Phase
Kidney Cancer Drug: bevacizumab Drug: RAD001 Phase 2

Detailed Description:

All eligible patients will receive:

  • Bevacizumab 10mg/kg, IV infusion, every 2 weeks
  • RAD001 10 mg by mouth daily

All patients will be evaluated for response after completing two courses (8 weeks) of treatment. Patients with objective tumor response or stable disease will continue treatment with bevacizumab adn RAD001 on the same schedule. Treatment will continue until disease progression occurs.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Bevacizumab(Avastin) and RAD001(Everolimus)in the Treatment of Patients With Advanced Clear Cell Renal Carcinoma
Study Start Date : May 2006
Actual Primary Completion Date : November 2008
Actual Study Completion Date : March 2011

Arm Intervention/treatment
Experimental: Bevacizumab and RAD001
Bevacizumab 10mg/kg, IV infusion, every 2 weeks RAD001 10 mg by mouth daily
Drug: bevacizumab
Bevacizumab 10mg/kg, IV infusion, every 2 weeks
Other Name: Avastin

Drug: RAD001
RAD001 10 mg by mouth daily
Other Name: Everolimus

Primary Outcome Measures :
  1. Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death [ Time Frame: 18 months ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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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.
  • In patients with mixed histologies, the clear cell component must comprise ≥ 75% of the cancer
  • Previous nephrectomy is required with the following exceptions:
  • Primary tumor < 5cm
  • Extensive liver ( > 30% of liver parenchyma)or
  • Multiple (> 5) bone metastases, making nephrectomy a clinically contraindicated procedure
  • Patients may have had a maximum of 1 previous systemic regimen for metastatic disease
  • Patients may not have received previous bevacizumab. However, patients who have received other agents with anti-angiogenic activity (eg. sorafenib, SU11248, AG-013736, PTK787, thalidomide) as part of first-line treatment are eligible
  • Patients may not have received previous treatment with m-TOR inhibitors.
  • ECOG performance status 0 or 1
  • Measurable disease
  • Adequate liver, kidney and bone marrow function
  • No previous systemic treatment or radiation therapy for at least 2 weeks prior to study entry
  • Patients must be able to understand the nature of this study and give written informed consent

Exclusion Criteria:

  • Age < 18 years
  • Treatment with > 1 previous systemic regimen for metastatic renal carcinoma
  • History of acute myocardial infarction within 6 months
  • Clinically significant cardiovascular disease
  • History of stroke within 6 months
  • Patients with active brain metastases
  • Patients with meningeal metastases
  • Women who are pregnant or lactating
  • Patients who have been treated within 5 years for other invasive cancers
  • Patients with history or evidence by physical examination of CNS disease
  • Patients with clinical history of hemoptysis or hematemesis
  • Patients with history of deep vein thrombosis or thromboembolic disease requiring full dose anticoagulation
  • Patients with major surgical procedures, open biopsies, or significant traumatic injuries within 28 days or anticipated need for major surgical procedure during the course of the study
  • Patients with peg-tubes or G-tubes
  • Patients are ineligible if a fine needle aspiration biopsy has been performed within seven days
  • Patients with proteinuria
  • Patients with any non-healing wound, ulcer, or long-bone fracture
  • Patients with any history of a bleeding diathesis or coagulopathy
  • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months
  • Patients who have received any other experimental drug within 28 days of starting treatment
  • History of any other severe and/or uncontrolled medical disease
  • History of HIV infection
  • Chronic treatment with steroids or other immunosuppressive agents
  • Patients with impaired GI function that compromises the ability to swallow or absorb RAD001
  • Patients who are unwilling or unable to comply with the protocol

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): NCT00323739

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United States, Florida
Florida Cancer Specialists
Fort Myers, Florida, United States, 33901
Gainsville Hematology Oncology Associates
Gainesville, Florida, United States, 32605
Integrated Community Oncology Network
Jacksonville, Florida, United States, 32256
Florida Hospital Cancer Institute
Orlando, Florida, United States, 32804
United States, Georgia
Wellstar Cancer Research
Marietta, Georgia, United States, 30060
United States, Kentucky
Consultants in Blood Disorders and Cancer
Louisville, Kentucky, United States, 40207
United States, Louisiana
Baton Rouge General Medical Center
Baton Rouge, Louisiana, United States, 70806
United States, Michigan
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, United States, 49503
United States, Nebraska
Methodist Cancer Center
Omaha, Nebraska, United States, 68114
United States, Ohio
Oncology Hematology Care
Cincinnati, Ohio, United States, 45242
United States, Tennessee
Chattanooga Oncology Hematology Associates
Chattanooga, Tennessee, United States, 37404
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37023
Sponsors and Collaborators
SCRI Development Innovations, LLC
Genentech, Inc.
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Principal Investigator: John D. Hainsworth, MD SCRI Development Innovations, LLC
Additional Information:
Publications of Results:
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Responsible Party: SCRI Development Innovations, LLC Identifier: NCT00323739    
Other Study ID Numbers: SCRI GU 32
First Posted: May 9, 2006    Key Record Dates
Results First Posted: March 6, 2013
Last Update Posted: July 26, 2013
Last Verified: July 2013
Keywords provided by SCRI Development Innovations, LLC:
kidney cancer
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
Immunosuppressive Agents
Immunologic Factors