Vatalanib and Everolimus in Treating Patients With Advanced Solid Tumors (PTK/RAD)
Kidney Cancer, Unspecified Adult Solid Tumor, Protocol Specific
About this trial
This is an interventional treatment trial for Kidney Cancer focused on measuring unspecified adult solid tumor, protocol specific, recurrent renal cell cancer, stage IV renal cell cancer
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
Sites / Locations
- Duke Comprehensive Cancer Center
Arms of the Study
Arm 1
Experimental
PTK787, RAD001
PTK787 (vatalinib) 1000 mg daily, RAD001 (everolimus) 5 mg daily