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Trial record 1 of 1 for:    NCT01070186
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Study of Sunitinib in Subjects With High Risk Renal Cell Carcinoma

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ClinicalTrials.gov Identifier: NCT01070186
Recruitment Status : Withdrawn (No participants were enrolled.)
First Posted : February 17, 2010
Last Update Posted : July 31, 2012
Sponsor:
Collaborator:
Pfizer
Information provided by:
Jonsson Comprehensive Cancer Center

Tracking Information
First Submitted Date  ICMJE February 16, 2010
First Posted Date  ICMJE February 17, 2010
Last Update Posted Date July 31, 2012
Study Start Date  ICMJE October 2010
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: February 16, 2010)
Time to clinical recurrence after surgery for high risk localized disease. [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 21, 2012)
  • Toxicity of Sunitinib when administered as neoadjuvant therapy prior to surgery [ Time Frame: 1 year ]
    Toxicities will be graded using the NCI Common Toxicity Criteria, version 3.0
  • Effect of Sunitinib on pretreatment serum levels of Vascular Endothelial Growth Factor (VEGF). Tissue levels (biopsy and pathological specimen) of total VEGF, HIF-alpha, microvessel density, and apoptotic indices (TUNNEL Staining) [ Time Frame: 1 year ]
  • Radiographically quantifiable evaluation of changes in cellular disorganization (marker of necrosis) and perfusion parameters before and during the administration of Sunitinib. [ Time Frame: 1 year ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 16, 2010)
  • To evaluate the safety of Sunitinib when administered as neoadjuvant therapy prior to surgery [ Time Frame: 1 year ]
  • To evaluate the effects of Sunitinib on pretreatment serum levels of VEGF. Tissue levels (biopsy and pathological specimen) of total VEGF, HIF-alpha, microvessel density, and apoptotic indices (TUNNEL Staining) [ Time Frame: 1 year ]
  • Radiographically quantifiable evaluation of changes in cellular disorganization (marker of necrosis) and perfusion parameters before and during the administration of Sunitinib. [ Time Frame: 1 year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Sunitinib in Subjects With High Risk Renal Cell Carcinoma
Official Title  ICMJE Phase II, Open Label, Single Center Study of Sunitinib in Subjects With High Risk Renal Cell Carcinoma
Brief Summary This study is designed to explore the molecular modulatory effect of Sunitinib when given in a neoadjuvant setting prior to radical or partial nephrectomy. The study will evaluate aforementioned outcomes in 30 patients at a dose of 50mg/day for 4 weeks followed by surgery 2-4 weeks following the last dose.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Renal Cell Carcinoma
Intervention  ICMJE
  • Drug: Sunitinib
    50mg/day for 4 weeks
    Other Name: Sutent
  • Other: Tumor biopsy
    Conducted prior to administration of sunitinib therapy
  • Procedure: Nephrectomy
    Nephrectomy 2-4 weeks after last dose of Sunitinib
  • Other: Biomarkers

    Biomarker evaluation of blood prior to treatment, after 4 weeks of Sunitinib administration, and every three months for a year after surgery.

    Biomarker evaluation of tissue prior to 4 week administration of Sunitinib

Study Arms  ICMJE Experimental: Treatment
See intervention descriptions
Interventions:
  • Drug: Sunitinib
  • Other: Tumor biopsy
  • Procedure: Nephrectomy
  • Other: Biomarkers
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 21, 2012)
0
Original Estimated Enrollment  ICMJE
 (submitted: February 16, 2010)
30
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients must be at least 18 years of age
  • Must be eligible to undergo a radical or partial nephrectomy
  • Clinical stage T1b, T2, T3, T4 and/or N1 disease as documented by abdomen/pelvis CT scan, or MRI and chest x-ray or CT chest
  • Patients must have a performance status on the ECOG scale of 0-1
  • Patients must have a pretreatment wbc > 3.0, granulocyte count > 1000/mm3, hemoglobin > 8.5 g/dL, platelet count > 100,000/mm3 and a normal PT and PTT
  • Patients must have a serum creatinine < 2.0 mg/dL
  • Patients must have adequate hepatic function with a serum bilirubin < upper limit of normal and AST/ALT < 2.5 x upper limit of normal

Exclusion Criteria:

  • Radiographic evidence of metastatic disease
  • Prior administration of immunotherapy/biotherapy/hormonal or radiation for renal cell carcinoma
  • Active secondary malignancies (other than basal cell carcinoma of the skin)
  • Serious, nonhealing wound, ulcer, or bone fracture
  • Clinically significant cardiovascular disease, New York Heart Association Grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication or Grade II or greater peripheral vascular disease within 1 year preceding Day 0
  • Any history or radiologic evidence of central nervous system disease
  • Active infection requiring parenteral antibiotics at the time of the first Sunitinib administration
  • Current or recent (within the 10 days preceding Day 0) use of oral or parenteral anticoagulants (except as required to maintain patency of preexisting, permanency indwelling IV catheters), or aspirin
  • Current, recent (within the 4 weeks preceding Day 0), or planned participation in another experimental drug study
  • Screening clinical laboratory values:

    • ANC of < 1000/uL
    • Platelet count of < 100,000/uL
    • Total bilirubin > 2.0 mg/dL
    • AST or ALT > 2.5 times the upper limit of normal
    • Serum creatinine of > 2.0 mg/dL
    • Hemoglobin of < 9 gm/dL (may be transfused to maintain or exceed this level)
    • Ongoing cardiac dysrhythmias of NCI CTCAE Version 3.0 grade > 2
    • Prolonged QTc interval on baseline EKG
    • Uncontrolled hypertension (>150/100 mm Hg despite optimal medical therapy)
    • Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication
    • Patients receiving CYP3A4 inducers or inhibitors; patients should not take grapefruit juice or St. John's Wort while on the study
    • History of psychiatric disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the subject at high risk from treatment complications
    • Unable to take medication by mouth
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 NCT01070186
Other Study ID Numbers  ICMJE 09-07-068
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fairooz Kabbinavar, MD / Principal Investigator, UCLA Jonsson Comprehensive Cancer Center
Study Sponsor  ICMJE Jonsson Comprehensive Cancer Center
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator: Fairooz Kabbinavar, M.D. University of California, Los Angeles
PRS Account Jonsson Comprehensive Cancer Center
Verification Date July 2012

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