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

• Status: Terminated
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Harry Drabkin
• Treatments: Sunitinib

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