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Trial record 1 of 1 for:    NCT00556205
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Bevacizumab With or Without Sunitinib in Sunitinib-Refractory Renal Cell Carcinoma

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ClinicalTrials.gov Identifier: NCT00556205
Recruitment Status : Withdrawn (Toxicity of combination from other trials)
First Posted : November 9, 2007
Last Update Posted : March 24, 2016
Sponsor:
Collaborators:
Beth Israel Deaconess Medical Center
Pfizer
Information provided by (Responsible Party):
Dror Michaelson, MD, Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE November 7, 2007
First Posted Date  ICMJE November 9, 2007
Last Update Posted Date March 24, 2016
Study Start Date  ICMJE September 2009
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 9, 2009)
To determine the time to tumor progression (TTP) in this patient population treated with bevacizumab or combination of sunitinib and bevacizumab. [ Time Frame: Until tumor progression ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 7, 2007)
To determine the time to tumor progression (TTP) in this patient population treated with continuous sunitinib, bevacizumab, or combination of sunitinib and bevacizumab. [ Time Frame: Until tumor progression ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 7, 2007)
  • To determine the overall response rate in this patient population. [ Time Frame: Until tumor progression ]
  • To evaluate the safety and tolerability of these treatments in mRCC patients with disease progression on standard dose sunitinib. [ Time Frame: Until tumor progression ]
  • To collect serum research samples for analysis of predictive biomarkers of response. [ Time Frame: Two months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bevacizumab With or Without Sunitinib in Sunitinib-Refractory Renal Cell Carcinoma
Official Title  ICMJE Phase II, Randomized Trial of Bevacizumab With or Without Sunitinib in Sunitinib-Refractory Patients With Metastatic Renal Cell Carcinoma
Brief Summary The purpose of this research study is to further define an effective strategy for people with renal cell carcinoma and to learn the safety and effectiveness of two different types of sunitinib-refractory treatments: Bevacizumab alone or a combination of sunitinib and bevacizumab. Sunitinib is an FDA approved drug and is currently one of the standard treatments for advanced renal cell carcinoma. However, some people who receive this treatment do not respond to treatment or they stop responding to treatment. Bevacizumab is an FDA approved drug used for the treatment of several cancers however, is not yet approved for use in renal cell carcinoma.
Detailed Description
  • Participants will receive one of two treatment possibilities. Since no one knows which of the study options is best, participants will be "randomized" to one fo the three treatment groups.
  • Group 1 will stop their current treatment with sunitinib and receive a dose of bevacizumab once every 2 weeks. Group 2 will receive the standard treatment of sunitinib with the addition of bevacizumab.
  • All study participants will undergo the same study procedures. These study procedures will include the following at intervals specified in the protocol: medical history review; vital signs; physical exam; urine analysis; EKG and CT scan.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Renal Cell Carcinoma
Intervention  ICMJE
  • Drug: Sunitinib
    Sunitinib orally once daily
    Other Name: sutent
  • Drug: Bevacizumab
    Intravenously every 14 days
    Other Name: avastin
Study Arms  ICMJE
  • Active Comparator: 1
    Bevacizumab monotherapy 10 mg/kg IV q2 weeks
    Intervention: Drug: Bevacizumab
  • Active Comparator: 2
    Combination Sunitinib & Bevacizumab Bevacizumab 10 mg/kg IV q2 weeks Sunitinib 50 mg PO QD on 4/2 schedule
    Interventions:
    • Drug: Sunitinib
    • Drug: Bevacizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: March 23, 2016)
0
Original Estimated Enrollment  ICMJE
 (submitted: November 7, 2007)
81
Actual Study Completion Date  ICMJE September 2009
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically confirmed metastatic renal cell carcinoma with clear cell histology
  • Patients must be off sunitinib for 14 days prior to day 1 of treatment on protocol
  • Evidence of unidimensionally measurable disease based on RECIST criteria, with at least 1 measurable lesion
  • Radiographic evidence of disease progression defined by RECIST during or within 6 weeks of completion of sunitinib treatment
  • Participants must have received at least 14 doses of sunitinib therapy
  • Participants must enroll within 3 months of the last dose of sunitinib
  • Males or females, age of 18 years or older
  • ECOG Performance status 0-2
  • Resolution of all acute toxic effects of prior therapy, radiotherapy or surgical procedures to NCI CTCAE version 3.0 grade 1 or less
  • Laboratory values as defined in protocol
  • 4 weeks or more must have elapsed from the time of major surgery and subjects must have recovered from the procedure prior to day 1 of randomization
  • No anticipated need for major surgical procedure during the course of the study
  • 2 weeks or more must have elapsed from the time of minor surgery and subjects must have recovered from the procedure prior to day 1 of randomization
  • 4 weeks of more must have elapsed from the time of major radiotherapy prior to day 1 of randomization

Exclusion Criteria:

  • Prior treatment with bevacizumab
  • Unacceptable toxicity on prior sunitinib therapy at 37.5mg or lower
  • Prior systemic therapy for RCC with > 2 regimens
  • Systemic therapy other than sunitinib within 4 weeks of starting the study treatment
  • Uncontrolled high blood pressure
  • Any prior history of hypertensive crisis or hypertensive encephalopathy
  • History of abdominal fistula, gastrointestinal perforation or intraabdominal abscess within 3 months prior to day 0
  • Any of the following within the 6 months prior to sudy drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, cerebrovascular accident or transient ischemic attack, symptomatic congestive heart failure, or ejection fraction < 30%
  • Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range without medication
  • History of or known brain metastases or spinal cord compression
  • NCI CTCAE grade 2 or above hemorrhage within 4 weeks of starting study treatment
  • Significant vascular disease (e.g., aortic aneurysm, aortic dissection)
  • Symptomatic peripheral vascular disease
  • Grade 3 or higher cardiac dysrhythmia or QT prolongation
  • Concurrent use of proarrhythmic medications including terfenadine, quinidine, procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone, indapamide and flecainide
  • Pregnancy or breastfeeding or inadequate contraception
  • Significant thromboembolic event within 6 months
  • Evidence of bleeding diathesis or coagulopathy
  • Serious, non-healing wound, ulcer or bone fracture
  • Proteinuria at screening
  • Known hypersensitivity to any component of bevacizumab
  • Psychiatric illness/social situation that would limit compliance with study requirements
  • Previous or concurrent malignancy requiring active systemic therapy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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 Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00556205
Other Study ID Numbers  ICMJE 07-202
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: No data to share
Responsible Party Dror Michaelson, MD, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE
  • Beth Israel Deaconess Medical Center
  • Pfizer
Investigators  ICMJE
Principal Investigator: M. Dror Michaelson, MD, PhD Massachusetts General Hosptial
PRS Account Massachusetts General Hospital
Verification Date March 2016

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