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Phase II, Open Label, Single Center Study of Sunitinib in Subjects With High Risk Renal Cell Carcinoma

Phase 2
18 Years
Not Enrolling
Renal Cell Carcinoma

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Trial Information

Phase II, Open Label, Single Center Study of Sunitinib in Subjects With High Risk Renal Cell Carcinoma

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

- 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

- 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

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to clinical recurrence after surgery for high risk localized disease.

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Fairooz Kabbinavar, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, Los Angeles


United States: Food and Drug Administration

Study ID:




Start Date:

October 2010

Completion Date:

Related Keywords:

  • Renal Cell Carcinoma
  • nephrectomy
  • T1b
  • T2
  • T3
  • T4
  • N1
  • Kidney Cancer
  • Carcinoma
  • Carcinoma, Renal Cell