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Interferon Alfa-2b With or Without Bevacizumab in Treating Patients With Advanced Renal Cell Carcinoma (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: NCT00072046
Recruitment Status : Completed
First Posted : November 6, 2003
Last Update Posted : July 6, 2016
National Cancer Institute (NCI)
NCIC Clinical Trials Group
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Tracking Information
First Submitted Date  ICMJE November 4, 2003
First Posted Date  ICMJE November 6, 2003
Last Update Posted Date July 6, 2016
Study Start Date  ICMJE October 2003
Actual Primary Completion Date January 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 28, 2011)
Overall Survival [ Time Frame: 5 years ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00072046 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 5, 2011)
  • Time to progression [ Time Frame: q 3 cycles ]
  • Toxicity [ Time Frame: q cycle ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Interferon Alfa-2b With or Without Bevacizumab in Treating Patients With Advanced Renal Cell Carcinoma (Kidney Cancer)
Official Title  ICMJE A Randomized Phase III Trial Of Interferon Alfa-2B Or Interferon Alfa-2B Plus Bevacizumab In Patients With Advanced Renal Carcinoma
Brief Summary

RATIONALE: Biological therapies, such as interferon alfa-2b, may interfere with the growth of tumor cells. Bevacizumab may stop the growth of tumor cells by stopping blood flow to the tumor. It is not yet known whether interferon alfa-2b is more effective with or without bevacizumab in treating advanced renal cell carcinoma (kidney cancer).

PURPOSE: This randomized phase III trial is studying interferon alfa-2b and bevacizumab to see how well they work compared to interferon alfa-2b alone in treating patients with advanced renal cell carcinoma.

Detailed Description



  • Compare the overall survival of patients with advanced renal cell carcinoma treated with interferon alfa-2b alone or interferon alfa-2b with bevacizumab.


  • Compare the time to disease progression and objective response rates in patients treated with these regimens.
  • Determine the toxicity of interferon alfa-2b in combination with bevacizumab in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior nephrectomy (yes vs no) and number of risk factors for disease progression (0 vs 1-2 vs 3 or more). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive interferon alfa-2b subcutaneously (SC) three times a week.
  • Arm II: Patients receive interferon alfa-2b as in arm I and bevacizumab IV over 30-90 minutes on days 1 and 15.

In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years and then annually for up to 10 years after study entry.

PROJECTED ACCRUAL: A total of 700 patients (350 per treatment arm) will be accrued for this study within 3 years.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Kidney Cancer
Intervention  ICMJE
  • Biological: bevacizumab
    10mg/kg IV infusion on Days 1 & 15 of each cycle
  • Biological: recombinant interferon alfa
    9 million units subQ injection 3 x/week for 4 weeks
Study Arms  ICMJE
  • Experimental: Interferon
    Treatment with interferon alfa 2b
    Intervention: Biological: recombinant interferon alfa
  • Experimental: Interferon + bevacizumab
    Addition of bevacizumab to interferon alfa 2b treatment
    • Biological: bevacizumab
    • Biological: recombinant interferon alfa
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 5, 2011)
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE November 2012
Actual Primary Completion Date January 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE


  • Histologically or cytologically confirmed renal cell carcinoma (RCC)

    • Conventional clear cell carcinoma
    • Metastatic or unresectable disease
  • The following characteristics and cellular types are excluded:

    • True papillary
    • Sarcomatoid features without a clear cell component
    • Chromophobe
    • Oncocytoma
    • Collecting duct tumor
    • Transitional cell carcinoma
  • Measurable or nonmeasurable disease, including any of the following:

    • Unidimensionally measurable lesion ≥ 20 mm by conventional techniques (e.g., physical exam or chest x-ray) OR 10 mm by spiral CT scan or MRI
    • The following are considered nonmeasurable disease:

      • Small lesions
      • Bone lesions
      • Leptomeningeal disease
      • Ascites
      • Pleural/pericardial effusion
      • Lymphangitis cutis/pulmonis
      • Abdominal masses that are not confirmed and followed by imaging techniques
      • Cystic lesions
      • Irradiated lesions, unless progression is documented after radiotherapy
  • RCC paraffin tissue blocks or unstained slides must be available
  • No evidence of prior or concurrent CNS metastases by MRI or CT scan



  • 18 and over

Performance status

  • Karnofsky 70-100%

Life expectancy

  • Not specified


  • Granulocyte count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • No history of clinically significant bleeding


  • AST/ALT ≤ 2.5 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 2.5 times ULN
  • Bilirubin ≤ 1.5 times ULN


  • Creatinine ≤ 1.5 times ULN
  • No proteinuria > 1+

    • Proteinuria ≥ 2+ allowed provided protein is < 2 g/24-hour urine collection


  • No deep venous thrombosis within the past year
  • No cerebrovascular accident within the past year
  • No peripheral vascular disease with claudication on < 1 block
  • No uncontrolled hypertension defined as blood pressure ≥160 mm Hg (systolic) and/or ≥ 90 mm Hg (diastolic) while on medication
  • No New York Heart Association class II-IV congestive heart failure
  • No angina pectoris requiring nitrate therapy
  • No myocardial infarction within the past 6 months
  • No other significant cardiovascular disease


  • No pulmonary embolus within the past year
  • No ongoing hemoptysis


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after study treatment
  • No preexisting thyroid abnormality in which normal thyroid function cannot be maintained by medication
  • No delayed wound healing, ulcers, or bone fractures
  • No uncontrolled psychiatric disorder
  • No other currently active* malignancy except nonmelanoma skin cancer NOTE: *Disease is not considered currently active if patient completed anticancer therapy and is considered to have < 30% risk of relapse


Biologic therapy

  • No prior systemic immunotherapy for RCC
  • No prior thalidomide, anti-vascular endothelial growth factor (VEGF) therapy, VEGF receptor inhibitors, or antiangiogenic treatment of any kind
  • No concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF)


  • No prior systemic chemotherapy for RCC
  • No concurrent chemotherapy

Endocrine therapy

  • No concurrent systemic corticosteroid therapy except the following:

    • Topical and inhaled steroids
    • Replacement therapy for adrenal insufficiency
  • No concurrent hormones except those administered for nondisease-related conditions (e.g., insulin for diabetes)


  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy and recovered
  • Prior palliative radiotherapy to metastatic lesions allowed provided at least 1 measurable or nonmeasurable lesion remains untreated
  • No concurrent palliative radiotherapy


  • At least 4 weeks since prior major surgery and recovered


  • No other prior systemic investigational therapy for RCC
  • No other prior adjuvant or neoadjuvant systemic therapy for RCC
  • No concurrent full-dose oral or parenteral anticoagulation* NOTE: *Low-dose (1 mg) warfarin for maintenance of catheter patency and/or daily prophylactic aspirin is allowed
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 120 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00072046
Other Study ID Numbers  ICMJE CALGB-90206
U10CA031946 ( U.S. NIH Grant/Contract )
CDR0000335292 ( Registry Identifier: NCI Physician Data Query )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alliance for Clinical Trials in Oncology
Study Sponsor  ICMJE Alliance for Clinical Trials in Oncology
Collaborators  ICMJE
  • National Cancer Institute (NCI)
  • NCIC Clinical Trials Group
Investigators  ICMJE
Study Chair: Brian I. Rini, MD University of California, San Francisco
PRS Account Alliance for Clinical Trials in Oncology
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP