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A Pilot Study of Neoadjuvant SUNITINIB MALATE (Sunitinib) in Patients With Renal Cell Carcinoma Undergoing Nephrectomy

18 Years
Not Enrolling
Kidney Cancer

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Trial Information

A Pilot Study of Neoadjuvant SUNITINIB MALATE (Sunitinib) in Patients With Renal Cell Carcinoma Undergoing Nephrectomy



- Determine the safety of sunitinib malate in patients with localized or metastatic renal
cell carcinoma.

- Determine the safety of surgery after 90 days of treatment with sunitinib malate in
these patients.


- Determine response of these patients after 90 days of treatment with sunitinib malate.

OUTLINE: Patients receive oral sunitinib malate once daily on days 1-90 in the absence of
disease progression or unacceptable toxicity. Patients then undergo radical nephrectomy.

After completion of study treatment, patients are followed for 3 months.

Inclusion Criteria


- Newly diagnosed renal cell carcinoma

- Clinical stage T1b, T2, or T3 tumor with or without nodal or hematogenous

- Localized or metastatic disease by renal biopsy

- Primary tumor must be amenable to surgical removal

- No history of or known spinal cord compression or carcinomatous meningitis OR
evidence of symptomatic brain or leptomeningeal disease by CT scan or MRI

- Treated, stable, and asymptomatic brain metastases are allowed


- ECOG performance status 0-1

- ANC ≥ 1,500/mm^3

- Platelets ≥ 100,000/mm^3

- Hemoglobin ≥ 9.0 g/dL

- AST and ALT ≤ 2.5 times upper limit of normal (ULN) (≤ 5 times ULN if liver function
abnormalities are due to underlying malignancy)

- Total bilirubin ≤ 1.5 times ULN

- Creatinine < 2 mg/dL OR creatinine clearance > 40 mL/min

- Calcium ≤ 10.2 mg/dL

- QTc interval < 500 msec

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective barrier contraception during and for 3 (male)-6
(female) months after completion of study treatment

- No serious intercurrent illness including, but not limited to, any of the following:

- Clinically significant cardiovascular disease (e.g., uncontrolled hypertension,
myocardial infarction, unstable angina)

- New York Heart Association ≥ class II congestive heart failure

- Serious cardiac arrhythmia requiring medication

- Peripheral vascular disease ≥ grade 2

- Psychiatric illness/social situations that would limit compliance with study

- None of the following conditions within the past 6 months:

- Myocardial infarction

- Severe/unstable angina

- Coronary/peripheral artery bypass graft

- Symptomatic congestive heart failure

- Cerebrovascular accident or transient ischemic attack

- Pulmonary embolism

- No ongoing cardiac dysrhythmias NCI CTCAE version 3.0 ≥ grade 2

- No hypertension that cannot be controlled by medications (i.e., diastolic blood
pressure > 100 mm Hg despite optimal medical therapy)

- No known HIV positivity


- Not specified

Type of Study:


Study Design:

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

Outcome Measure:

Safety of sunitinib malate (SM)

Outcome Time Frame:

90 days

Safety Issue:


Principal Investigator

Willie Underwood, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

August 2007

Completion Date:

April 2010

Related Keywords:

  • Kidney Cancer
  • stage I renal cell cancer
  • stage II renal cell cancer
  • stage III renal cell cancer
  • stage IV renal cell cancer
  • Carcinoma, Renal Cell
  • Kidney Neoplasms



Roswell Park Cancer InstituteBuffalo, New York  14263