Clinical trial NCT00459875 (phase 2, status: completed)
Conditions: kidney cancer
ICD codes: D17.71, D30.00, D30.01, D30.02, D41.00, D41.01, D41.02
Drugs: sunitinib malate
SMILES: CCN(CC)CCNC(=O)C1=C(C)NC(\C=C2/C(=O)NC3=C2C=C(F)C=C3)=C1C
Eligibility criteria:

        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