Sunitinib in Treating Patients With Locally Recurrent or Metastatic Kidney Cancer

Study Overview
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Brief Summary
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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. PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with locally recurrent or metastatic kidney cancer.

Detailed Description
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OBJECTIVES: Primary Determine the efficacy of sunitinib malate in patients with locally recurrent or metastatic papillary renal cell carcinoma. OUTLINE: Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 28 days and every 2 months thereafter.

Official Title
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Phase II Study of Sunitinib in Patients With Metastatic Papillary Renal Cell Carcinoma

Conditions
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Kidney Cancer

Intervention / Treatment
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* Drug: sunitinib malate


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed advanced renal cell carcinoma of papillary or other non-clear cell histology Metastatic or locally recurrent disease Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan The following are considered nonmeasurable disease: Bone lesions Ascites Peritoneal carcinomatosis or miliary lesions Pleural or pericardial effusions Lymphangitis of the skin or lung Cystic lesions Irradiated lesions Patients with primary tumor in place who are eligible for surgery must have undergone prior partial or radical nephrectomy No history of or known brain metastases, spinal cord compression, or evidence of symptomatic brain or leptomeningeal carcinomatosis PATIENT CHARACTERISTICS: Karnofsky performance status 70-100% Absolute neutrophil count ≥ 1,500/mm³ Platelet count ≥ 100,000/mm³ Hemoglobin ≥ 9.0 g/dL Calcium ≤ 12.0 mg/dL Creatinine ≤ 1.5 times upper limit of normal (ULN) Bilirubin ≤ 1.5 times ULN AST and ALT ≤ 2.5 times ULN (5 times ULN if liver function abnormalities are due to underlying malignancy) Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No hemorrhage ≥ grade 3 within the past 4 weeks No diagnosis of any second malignancy within the past 5 years, except for adequately treated basal cell carcinoma, squamous cell skin cancer, or in situ cervical cancer None of the following within the past 6 months: Myocardial infarction Severe or unstable angina Coronary or peripheral artery bypass graft Symptomatic congestive heart failure Cerebrovascular accident or transient ischemic attack Pulmonary embolism No ongoing cardiac dysrhythmias ≥ grade 2 or atrial fibrillation of any grade No prolongation of the QTc interval to > 450 msec (males) or > 470 msec (females) No uncontrolled hypertension (i.e., blood pressure > 150/100 mm Hg despite optimal medical therapy) No pre-existing thyroid abnormality, with thyroid function tests that cannot be maintained in the normal range with medication No known HIV or AIDS-related illness No other active infection No other severe acute or chronic medical or psychiatric condition or laboratory abnormality that would preclude study compliance PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior sunitinib malate Prior or concurrent bisphosphonates allowed More than 4 weeks since prior radiotherapy and recovered Prior palliative radiotherapy to metastatic lesions allowed provided there is ≥ 1 measurable lesion that has not been irradiated More than 4 weeks since prior major surgery and recovered No concurrent therapeutic doses of warfarin Low-dose warfarin ≤ 2 mg daily for thromboprophylaxis allowed Concurrent low molecular weight heparin for full anticoagulation allowed No other concurrent approved or investigational anticancer treatment, including chemotherapy, biological response modifiers, hormonal therapy, or immunotherapy No other concurrent investigational drugs No concurrent treatment on another clinical trial Concurrent participation on supportive care trials or nontreatment trials (e.g., quality of life trials) allowed

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sunitinib<br>The treatment will include Sunitinib malate 50 mg self-administered orally, once daily in the evening, without regard to meals, for 4 consecutive weeks (28 days) followed by 2 weeks (14 days) off, to comprise a complete cycle of 6 weeks. | Drug: sunitinib malate<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Objective Response Rate as Measured by RECIST |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent renal cell cancer, stage IV renal cell cancer