title: Sorafenib and everolimus in advanced clear cell renal carcinoma: a phase I/II trial of the SCRI Oncology Research Consortium.
abstract: OBJECTIVE
  To evaluate the feasibility and efficacy of sorafenib and everolimus in renal cell carcinoma (RCC).
  
  
  METHODS
  Patients with advanced RCC and ≤ 1 previous targeted therapy were treated.
  
  
  RESULTS
  Maximum tolerated doses were sorafenib 200 mg PO BID, everolimus 35 mg PO once weekly. Dose-limiting toxicity was hand-foot syndrome. The response rate was 13%; median PFS was 5.45 months (95% CI: 3.8-7.6). Skin toxicity, fatigue, hypertension, proteinuria, and mucositis (usually Grade 2) were common.
  
  
  CONCLUSIONS
  Fifty percent doses of sorafenib and everolimus were required when these drugs were combined. No increase in efficacy was suggested; toxicity was modestly increased.
authors.affiliation: Sarah Cannon Research Institute, Nashville, TN 37203, USA. jhainsworth@tnonc.com
authors.forename: John D
authors.initials: JD
authors.lastname: Hainsworth
authors.forename: David M
authors.initials: DM
authors.lastname: Waterhouse
authors.forename: William C
authors.initials: WC
authors.lastname: Penley
authors.forename: Dianna L
authors.initials: DL
authors.lastname: Shipley
authors.forename: Dana S
authors.initials: DS
authors.lastname: Thompson
authors.forename: Charles D
authors.initials: CD
authors.lastname: Webb
authors.forename: F
authors.initials: F
authors.lastname: Anthony Greco
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002292:Carcinoma, Renal Cell / Q000188:drug therapy* / Q000556:secondary; D018572:Disease-Free Survival; D000068338:Everolimus; D005260:Female; D060831:Hand-Foot Syndrome / Q000209:etiology; D006801:Humans; D007680:Kidney Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000556:secondary; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009536:Niacinamide / Q000008:administration & dosage / Q000031:analogs & derivatives; D010671:Phenylurea Compounds / Q000008:administration & dosage; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077157:Sorafenib; D016896:Treatment Outcome
chemical_list: D010671:Phenylurea Compounds; D009536:Niacinamide; D000068338:Everolimus; D000077157:Sorafenib; D020123:Sirolimus