title: Phase II trial of capecitabine and weekly docetaxel in metastatic renal cell carcinoma.
abstract: OBJECTIVE
  To evaluate the toxicity and efficacy of capecitabine and weekly docetaxel in a phase II clinical trial.
  
  
  METHODS
  Eligibility included metastatic renal cancer with a maximum of 2 prior regimens, performance status of 0-2, and adequate renal, hepatic, and bone marrow function. Docetaxel was administered intravenously at a dose of 36 mg/m(2) weekly on days 1, 8, and 15 of a 28- day cycle and capecitabine was administered orally at a dose of 1800 mg/m(2) from days 5-18. Toxicity was assessed on days 1, 8, and 15 of each cycle, and response was evaluated every 2 cycles.
  
  
  RESULTS
  Twenty-five patients, 19 white and 6 African American, were enrolled on this phase II trial. The median age was 60 years (range: 39-75 years). Eighteen patients had clear cell histology, 7 had papillary, sarcomatoid, or chromophobe histology. Thirteen had liver/bone metastases and 13 had >or=2 of the Memorial Sloan-Kettering Cancer Center prognostic risk factors. Twelve patients received prior immunotherapy. A total of 93 cycles were administered; median of 3 cycles and range from 0-10 cycles. The therapy was well tolerated. No treatment-related mortality was observed and 2 treatment-related hospitalizations for nausea, diarrhea, and dehydration occurred. Ten patients had stable disease. The median time to progression was 1.7 months and median survival was 11.1 months.
  
  
  CONCLUSIONS
  The combination of capecitabine and docetaxel was well tolerated in metastatic renal cancer. Clinical activity was predominantly noted in non-clear cell histology in which chemotherapy would be worthy of future investigation.
authors.affiliation: Division of Oncology, Department of Medicine, Barbara Ann Karmanos Cancer Institute, Wayne State University, Detroit, Michigan, USA. smarur1@jhmi.edu
authors.forename: Shanthi
authors.initials: S
authors.lastname: Marur
authors.forename: James
authors.initials: J
authors.lastname: Eliason
authors.forename: Lance K
authors.initials: LK
authors.lastname: Heilbrun
authors.forename: Brenda
authors.initials: B
authors.lastname: Dickow
authors.forename: Daryn W
authors.initials: DW
authors.lastname: Smith
authors.forename: Karen
authors.initials: K
authors.lastname: Baranowski
authors.forename: Samir
authors.initials: S
authors.lastname: Alhasan
authors.forename: Ulka
authors.initials: U
authors.lastname: Vaishampayan
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000964:Antimetabolites, Antineoplastic / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D000069287:Capecitabine; D002292:Carcinoma, Renal Cell / Q000188:drug therapy* / Q000556:secondary*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077143:Docetaxel; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives; D006801:Humans; D007680:Kidney Neoplasms / Q000188:drug therapy* / Q000473:pathology*; D008297:Male; D008875:Middle Aged; D043823:Taxoids / Q000008:administration & dosage
chemical_list: D000964:Antimetabolites, Antineoplastic; D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D000069287:Capecitabine; D005472:Fluorouracil