Bevacizumab in Treating Patients With Unresectable or Metastatic Kidney Cancer

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: NCT00601926
Recruitment Status : Terminated (Poor patient accrual. Attempts to open at other sites unsuccessful.)
First Posted : January 28, 2008
Results First Posted : February 18, 2015
Last Update Posted : June 15, 2015
Genentech, Inc.
Information provided by (Responsible Party):
Paul Monk, Ohio State University Comprehensive Cancer Center

Brief Summary:

RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of kidney cancer by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying the side effects and how well bevacizumab works in treating patients with unresectable or metastatic kidney cancer.

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

Detailed Description:



  • To evaluate the progression-free survival when bevacizumab is administered to patients with unresectable and/or metastatic papillary renal cell carcinoma.
  • To further evaluate the safety of bevacizumab in these patients.


  • To examine, in a preliminary manner, the response rate to bevacizumab in these patients.
  • To collect and store blood and urine samples for future analysis.
  • To evaluate overall survival when bevacizumab is administered to these patients.

OUTLINE: Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for 3 years.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial Of Avastin (Bevacizumab) In Patients With Metastatic Papillary Renal Cell Carcinoma
Study Start Date : February 2008
Actual Primary Completion Date : August 2011
Actual Study Completion Date : May 2013

Arm Intervention/treatment
Experimental: Bevacizumab
15 mg/kg over 90 minutes
Biological: bevacizumab
15 mg/kg over 90 minutes every 3 weeks
Other Name: Avastin

Primary Outcome Measures :
  1. Progression Free Survival (PFS) When Bevacizumab is Administered to Patients With Unresectable and/or Metastatic Papillary Renal Cell Carcinoma. [ Time Frame: Up to 2 years ]
    Progression was defined by using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) 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.

  2. Response Rate to Bevacizumab in This Population. [ Time Frame: Up to 2 years ]
    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response, Disappearance of all target lesions; Partial Response, >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease, 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; Stable Disease, neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, no occurrence of progression disease for non-target lesions, and no new lesions.

Secondary Outcome Measures :
  1. Safety of Bevacizumab in This Population of Patients [ Time Frame: Up to 2 years ]
    Grade 3 or higher toxicities according to CTCAE version 3.0

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


  • Histologically confirmed papillary renal cell carcinoma (RCC)

    • Unresectable and/or metastatic disease
  • Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension and is ≥ 10 mm by spiral CT scan
  • No known CNS (central nervous system) disease


Inclusion criteria:

  • ECOG (Eastern Cooperative Oncology Group) performance status 0-1
  • Life expectancy > 6 months
  • ANC (absolute neutrophil count) ≥ 1,000/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 10.0 g/dL
  • Total bilirubin ≤ 2.0 mg/dL
  • AST (aspartate aminotransferase) and ALT (Alanine transaminase) < 3 times normal
  • Creatinine clearance > 50 mg/mL
  • Calcium < 12 mg/dL (when corrected for level of serum albumin)
  • No known HIV infection
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

Exclusion criteria:

  • Inadequately controlled hypertension (defined as systolic blood pressure [BP] > 150 mm Hg and/or diastolic BP > 100 mm Hg on antihypertensive medications)
  • Prior history of hypertensive crisis or hypertensive encephalopathy
  • New York Heart Association class II-IV congestive heart failure
  • Myocardial infarction or unstable angina within the past 6 months
  • Stroke or transient ischemic attack within the past 6 months
  • Significant vascular disease (e.g., aortic aneurysm or aortic dissection)
  • Symptomatic peripheral vascular disease
  • Evidence of bleeding diathesis or coagulopathy
  • Significant traumatic injury within the past 28 days
  • Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
  • Serious, non-healing wound, ulcer, or bone fracture
  • Proteinuria at screening as demonstrated by either of the following:

    • Urine protein:creatinine (UPC) ratio ≥ 1.0 at screening
    • Urine dipstick for proteinuria ≥ 2+ OR 24-hour urine protein > 1g
  • Known hypersensitivity to any component of bevacizumab


  • No prior systemic treatment for metastatic papillary RCC
  • At least 4 weeks since prior palliative radiotherapy of painful areas
  • More than 28 days since prior major surgical procedure or open biopsy
  • No concurrent major surgical procedure
  • More than 7 days since prior core biopsy or other minor surgical procedure, excluding placement of a vascular access device
  • Concurrent low-dose acetylsalicylic acid (≤ 325 mg/day) allowed in patients at high-risk for arterial thromboembolic disease

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): NCT00601926

United States, Ohio
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Paul Monk
Genentech, Inc.
Principal Investigator: Paul Monk, MD Ohio State University

Additional Information:
Responsible Party: Paul Monk, Principal Investigator, Ohio State University Comprehensive Cancer Center Identifier: NCT00601926     History of Changes
Other Study ID Numbers: OSU-06111
NCI-2011-03160 ( Registry Identifier: Clinical Trial Reporting Program (CTRP) )
First Posted: January 28, 2008    Key Record Dates
Results First Posted: February 18, 2015
Last Update Posted: June 15, 2015
Last Verified: May 2015

Keywords provided by Paul Monk, Ohio State University Comprehensive Cancer Center:
papillary renal cell carcinoma
stage III renal cell cancer
stage IV renal cell cancer

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