Status:
COMPLETED
Sunitinib and Surgery in Treating Patients With Localized or Metastatic Kidney Cancer
Lead Sponsor:
Roswell Park Cancer Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Kidney Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 tum...
Detailed Description
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 suniti...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00849186
Start Date
August 1 2007
End Date
April 1 2010
Last Update
February 6 2015
Active Locations (1)
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1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001