Status:
TERMINATED
Sunitinib Before and After Surgery in Treating Patients With Metastatic Kidney Cancer That Can Be Removed By Surgery
Lead Sponsor:
Harry Drabkin
Conditions:
Kidney Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE1
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: * To describe the gene expression of VEGF and non-VEGF angiogenic growth factor genes in kidney cancer specimens from patients with metastatic renal cell carcinoma treated with sunitinib ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of clear cell renal cell carcinoma
- Metastatic disease
- Primary tumor is considered amenable to surgery
- Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension (longest diameter to be recorded) as \> 20 mm by conventional techniques or as \> 10 mm by spiral CT scan
- No untreated brain metastases
- Treated brain metastases allowed provided lesion has been stable on two consecutive CT or MRI scans separated by ≥ 2 months
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Leukocytes ≥ 3,000/μL
- ANC ≥ 1,500/μL
- Platelet count ≥ 75,000/μL
- Hemoglobin ≥ 8.5 g/dL
- Total Bilirubin ≤ 2 times upper limits of normal (ULN)
- AST and ALT ≤ 2.5 times ULN
- Creatinine ≤ 2.5 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Able to undergo nephrectomy and treatment with sunitinib malate
- No history of allergic reactions attributed to compounds of similar chemical or biological composition to sunitinib malate
- No uncontrolled intercurrent illness including, but not limited to, any of the following:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Psychiatric illness/social situations that would limit compliance with study requirements
- PRIOR CONCURRENT THERAPY:
- No prior systemic treatment with sunitinib malate
- No other concurrent investigational agents
- No concurrent combination antiretroviral therapy for HIV-positive patients
- Concurrent medications or substances known to affect, or with the potential to affect, the activity or pharmacokinetics of sunitinib malate allowed at the discretion of the principal investigator
Exclusion
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00747305
Start Date
October 1 2008
End Date
July 1 2014
Last Update
October 22 2015
Active Locations (1)
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1
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States, 29425