Kidney Cancer Clinical Trial

Sunitinib Before and After Surgery in Treating Patients With Metastatic Kidney Cancer That Can Be Removed By Surgery

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 tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving it after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This clinical trial is studying how well sunitinib works when given before and after surgery in treating patients with metastatic kidney cancer that can be removed by surgery.

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Full 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 malate.
To describe the association between quantitative gene expression levels of VEGF and non-VEGF angiogenic factors and clinical efficacy of this drug, as measured by response, duration of response, and time to progression in these patients.

OUTLINE: Patients receive oral sunitinib malate once daily for 8 weeks. Within 2 weeks after completion of neoadjuvant chemotherapy, patients undergo a nephrectomy and evaluation for response to therapy. Beginning 4-8 weeks after surgery patients resume oral sunitinib malate once daily for up to 12 months in the absence of disease progression or unacceptable toxicity.

Patients with disease progression after 8 weeks of adjuvant treatment receive treatment off study with other agents.

Viable (non-necrotic) tumor and non-tumor kidney tissue samples are obtained at the time of nephrectomy for correlative biomarker studies. Tissue samples are analyzed for gene expression of VEGF and non-VEGF angiogenic factors by real-time RT-PCR, western blot, and/or IHC. Blood samples are obtained at baseline and at 4 and 8 weeks for evaluation of circulating levels of VEGF and selected chemokines.

After completion of study therapy, patients are followed monthly.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Kidney Cancer

Phase:

Phase 1

Estimated Enrollment:

17

Study ID:

NCT00747305

Recruitment Status:

Terminated

Sponsor:

Harry Drabkin

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There is 1 Location for this study

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Hollings Cancer Center at Medical University of South Carolina
Charleston South Carolina, 29425, United States

How clear is this clinincal trial information?

Study is for people with:

Kidney Cancer

Phase:

Phase 1

Estimated Enrollment:

17

Study ID:

NCT00747305

Recruitment Status:

Terminated

Sponsor:


Harry Drabkin

How clear is this clinincal trial information?

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