Sunitinib and Surgery in Treating Patients With Localized or Metastatic Kidney Cancer

Study Overview
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Brief Summary
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RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving sunitinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This clinical trial is studying the side effects of giving sunitinib before surgery and to see how well it works in treating patients with localized or metastatic kidney cancer.

Detailed Description
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OBJECTIVES: Primary 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. Secondary 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.

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

Conditions
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Kidney Cancer

Intervention / Treatment
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* Drug: sunitinib malate
* Procedure: neoadjuvant therapy
* Procedure: therapeutic conventional surgery


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Newly diagnosed renal cell carcinoma Clinical stage T1b, T2, or T3 tumor with or without nodal or hematogenous metastasis 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 PATIENT CHARACTERISTICS: 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 requirements 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 PRIOR CONCURRENT THERAPY: Not specified

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: sunitinib malate<br>* oral<br>Procedure: neoadjuvant therapy<br>* IV<br>Procedure: therapeutic conventional surgery<br>* Surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of Sunitinib Malate (SM) | Incident Rate: The proportion of the population who experience a grade 3 or higher endpoint-relevant toxic event within 3 months of the beginning of treatment. | 90 days | 
| Safety of Surgery After 90 Days of Treatment With SM | Incident Rate: Intraoperative Complication Rate | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Rate After 90 Days of Treatment With SM |  | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I renal cell cancer, stage II renal cell cancer, stage III renal cell cancer, stage IV renal cell cancer