Clinical trial NCT00303732 (phase 1, status: completed)
Conditions: kidney cancer, unspecified adult solid tumor, protocol specific
ICD codes: D17.71, D30.00, D30.01, D30.02, D41.00, D41.01, D41.02, H01.009, H02.209, H02.009, H02.109, H04.209, H05.409, H10.509
Drugs: rad001 (everolimus), ptk787 (vatalanib)
SMILES: [H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\C=C(C)\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\C=C\C=C\C=C(C)\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC, ClC1=CC=C(NC2=NN=C(CC3=CC=NC=C3)C3=CC=CC=C23)C=C1
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed solid tumor with radiographic evidence of metastatic disease

               -  No standard therapy exists (phase I)

               -  Unresectable or metastatic renal cell carcinoma (phase Ib)

        PATIENT CHARACTERISTICS:

          -  Karnofsky performance status 70-100%

          -  Absolute neutrophil count ≥ 1,500/mm³

          -  Platelet count ≥ 100,000/mm³

          -  Hemoglobin ≥ 9 g/dL

          -  AST or ALT ≤ 2.5 times upper limit of normal (ULN)

          -  Total cholesterol < 300 mg/dL

          -  Triglycerides < 350 mg/dL

          -  Bilirubin ≤ 1.5 times ULN

          -  Creatinine ≤ 1.5 times ULN OR creatinine clearance > 40 mL/min

          -  Negative proteinuria by dip stick OR total urinary protein ≤ 500 mg

          -  No uncontrolled high blood pressure, history of labile hypertension, or history of
             poor compliance with antihypertensive regimen

          -  No unstable angina pectoris

          -  No symptomatic congestive heart failure (New York Heart Association class III or IV
             heart disease)

          -  No uncontrolled serious cardiac arrhythmia (symptomatic supraventricular tachycardia
             or any ventricular tachycardia/fibrillation)

          -  No myocardial infarction in the past 6 months

          -  No uncontrolled diabetes

          -  No interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the
             lung

          -  No active or uncontrolled infection

          -  No uncontrolled hyperlipidemia

          -  No chronic renal disease

          -  No acute or chronic liver disease (e.g., hepatitis or cirrhosis)

          -  No impaired gastrointestinal (GI) function OR GI disease that may significantly alter
             the absorption of vatalanib or everolimus, including any of the following:

               -  Ulcerative disease

               -  Uncontrolled nausea and vomiting with solid food

               -  Watery diarrhea > 5 times daily

               -  Malabsorption syndrome

               -  Bowel obstruction

               -  Inability to swallow the tablets

          -  No confirmed HIV infection

          -  Not pregnant

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No other concurrent severe and/or uncontrolled medical condition that would preclude
             study participation

        PRIOR CONCURRENT THERAPY:

          -  Recovered from prior therapy

          -  No prior antivascular endothelial growth factor therapy

          -  More than 4 weeks since prior major surgery* (laparotomy)

          -  More than 2 weeks since prior minor surgery*

          -  More than 4 weeks since prior chemotherapy (6 weeks for mitomycin C or nitrosoureas)

          -  More than 6 weeks since prior antibody therapy

          -  More than 2 weeks since prior biologic/immunotherapy

          -  More than 2 weeks since prior limited-field radiotherapy

          -  More than 4 weeks since prior full-field radiotherapy

          -  More than 4 weeks since prior investigational agents

          -  Prior transfusions allowed provided blood counts are stable for > 2 weeks

          -  Concurrent epoetin alfa allowed

          -  No concurrent warfarin or similar oral anticoagulants that are metabolized by the
             cytochrome P450 system

               -  Heparin and low molecular weight heparin allowed NOTE: *Insertion of a vascular
                  access device is not considered major or minor surgery