Everolimus and Imatinib Mesylate in Treating Patients With Metastatic or Unresectable Kidney Cancer
Kidney Cancer
About this trial
This is an interventional treatment trial for Kidney Cancer focused on measuring stage III renal cell cancer, stage IV renal cell cancer, clear cell renal cell carcinoma, recurrent renal cell cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed clear cell kidney cancer, meeting 1 of the following criteria: Measurable metastatic disease Locally unresectable disease No history of known brain metastases that have not been adequately treated with radiotherapy and/or surgery Must have received ≥ 1 prior systemic therapy for metastatic or unresectable renal cell carcinoma PATIENT CHARACTERISTICS: Eastern Cooperative Oncology Group (ECOG) performance status 0-2 Absolute neutrophil count > 1,500/mm³ Platelet count > 100,000/mm³ Hemoglobin > 8 g/dL Bilirubin < 1.5 times upper limit of normal (ULN) Serum glutamic oxaloacetic transaminase(SGOT) and Serum glutamic pyruvic transaminase(SGPT) < 2.5 times ULN Creatinine < 1.5 times ULN No New York Heat Association grade III-IV cardiac disease No other malignancy within the past 5 years except basal cell skin cancer, cervical carcinoma in situ, or insignificant or inactive disease No chronic liver disease (i.e., chronic active hepatitis or cirrhosis) No severe or uncontrolled medical disease No gastrointestinal disease or impairment that would hinder the absorption of everolimus No uncontrolled diabetes No chronic renal disease No active uncontrolled infection No congestive heart failure No myocardial infarction within the past 6 months PRIOR CONCURRENT THERAPY: See Disease Characteristics More than 2 weeks since prior major surgery More than 4 weeks since prior chemotherapy (6 weeks for nitrosourea or mitomycin C) More than 4 weeks since prior immunotherapy More than 4 weeks since other prior investigational agents No prior radiotherapy to > 25% of bone marrow No prior treatment with an mammalian target of rapamycin(mTOR) inhibitor No concurrent therapeutic warfarin
Sites / Locations
- OHSU Knight Cancer Institute
Arms of the Study
Arm 1
Experimental
Everolimus and Imatinib Mesylate
Everolimus: 2.5 mg daily by mouth Imatinib Mesylate: 600 mg daily by mouth