Study of Sunitinib in Subjects With High Risk Renal Cell Carcinoma

NCT01070186

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Renal Cell Carcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Advanced Information
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