Intervention: Sunitinib
Trial phase: Phase 2
ATC code: L01EX01
SMILES: CCN(CC)CCNC(=O)c1c(C)[nH]c(/C=C2\C(=O)Nc3ccc(F)cc32)c1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 37
Group description: Patients receive oral sunitinib malate once daily on days 1-14 and 22-35. Each cycle was 42 days (6 weeks) and was to be repeated for a total of one year.
Eligibility criteria:
Inclusion Criteria:

Histologically confirmed* renal cell carcinoma of any subtype containing any sarcomatoid features NOTE: *Patients must have a paraffin-embedded tumor specimen from the kidney or metastatic site available for central review and confirmation of tumor histology
Measurable advanced disease that is not resectable by surgery
Patients with resected or radiated brain metastases or those treated with stereotactic radiation therapy are eligible, provided they have been off steroids for at least 2 weeks

More than 2 weeks since prior radiotherapy and recovered

Previously irradiated lesions must not be the sole site of disease
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Absolute neutrophil count (ANC) ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Hemoglobin ≥ 9.0 g/dL (transfusions allowed)
Serum creatinine clearance ≥ 30 mL/min
serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) ≤ 2.5 times upper limit of normal (ULN; ≤ 5 times ULN in the presence of liver metastases)
Total bilirubin ≤ 1.5 times ULN
Baseline corrected QT interval < 500 msec on EKG
Able to swallow pills
Negative pregnancy test
Fertile patients must use effective contraception before and during study treatment
More than 2 weeks since prior and no concurrent ketoconazole, dexamethasone, dysrhythmic drugs (terfenadine, quinidine, procainamide, sotalol, probucol, bepridil, indapamide, or flecainide), haloperidol, risperidone, rifampin, grapefruit, or grapefruit juice
Patients with a history of prior malignancy are eligible provided they were treated with curative intent and have been disease free for the time period considered appropriate to not interfere with the outcome of this study

Exclusion Criteria:

Collecting duct or medullary carcinoma
Prior systemic therapy for metastatic disease. One prior therapeutic regimen with a non-tyrosine kinase inhibitor, such as an mtor inhibitor is allowed. Patients who were randomized to placebo on an adjuvant study are eligible
History of stroke within the past 6 months.
Pregnant or nursing

Clinically significant cardiovascular disease, defined as one of the following:

Uncontrolled hypertension (blood pressure > 150/100 mm Hg at the time of enrollment); patients with hypertension and BP ≤ 150/100 mm Hg on stable antihypertensive regimen are eligible
History of myocardial infarction or unstable angina within the past 24 weeks
New York heart association grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication, unstable angina pectoris
Peripheral vascular disease ≥ grade II
Ongoing ventricular cardiac dysrhythmias ≥ grade 2 as assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4
History of serious ventricular arrhythmia (ventricular tachycardia or ventricular fibrillation > 3 beats in a row)
Ongoing atrial fibrillation
Pre-existing thyroid abnormality with thyroid-stimulating hormone that cannot be maintained at less than or within the normal range with medication
Serious concurrent illness or active infection that would jeopardize the ability of the patient to receive study treatment
Known HIV