title: A dose escalation study of the biweekly administration of paclitaxel, oxaliplatin and capecitabine in patients with advanced solid tumors.
abstract: OBJECTIVE
  To determine the dose-limiting toxicities (DLTs) and the maximum-tolerated doses of the paclitaxel, oxaliplatin (LOHP) and capecitabine combination in patients with advanced solid tumors.
  
  
  METHODS
  Patients received escalating doses of paclitaxel (starting dose 100 mg/m2) and LOHP (starting dose 40 mg/m2) on days 1 and 15 and capecitabine (starting dose 800 mg/m2/day) on days 1-7 and 15-21 every 28 days. DLTs were evaluated in the first cycle.
  
  
  RESULTS
  Sixteen patients were treated at four dose-escalating levels. Eleven (68.7%) patients had received two or more prior chemotherapy regimens. The DLT level was reached at paclitaxel 110 mg/m2, LOHP 50 mg/m2 and capecitabine 1,000 mg/m2/day. DLTs due to grade 2-3 neutropenia resulted in treatment delays. No febrile neutropenia or treatment-related death occurred. Grade 2-3 neutropenia occurred in 3 (19%) patients each, grade 2-4 fatigue affected 6 (37.5%) patients, and grade 2-3 neurotoxicity was observed in 2 (12.5%) and 1 (6%) patients, respectively. Two partial responses and four disease stabilizations were achieved.
  
  
  CONCLUSIONS
  The recommended doses for phase II studies are paclitaxel 100 mg/m2 and LOHP 50 mg/m2 on days 1 and 15 and capecitabine 1,000 mg/m2/day on days 1-7 and 15-21 every 4 weeks. This regimen is well tolerated and merits further evaluation.
authors.affiliation: Department of Medical Oncology, University General Hospital of Heraklion, Heraklion, Greece.
authors.forename: Zacharenia
authors.initials: Z
authors.lastname: Saridaki
authors.forename: Vasiliki
authors.initials: V
authors.lastname: Bozionelou
authors.forename: Nikolaos
authors.initials: N
authors.lastname: Kentepozidis
authors.forename: Athanasios
authors.initials: A
authors.lastname: Kotsakis
authors.forename: Nikolaos
authors.initials: N
authors.lastname: Vardakis
authors.forename: Antonia
authors.initials: A
authors.lastname: Kalykaki
authors.forename: Ioannis
authors.initials: I
authors.lastname: Gioulbasanis
authors.forename: Athanasios
authors.initials: A
authors.lastname: Karampeazis
authors.forename: Athanasios
authors.initials: A
authors.lastname: Karabeazis
authors.forename: Lambros
authors.initials: L
authors.lastname: Vamvakas
authors.forename: Vassilis
authors.initials: V
authors.lastname: Georgoulias
authors.forename: Dimitris
authors.initials: D
authors.lastname: Mavroudis
mesh_terms: D000328:Adult; D000368:Aged; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects; D000069287:Capecitabine; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives; D009369:Neoplasms / Q000188:drug therapy; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D000077150:Oxaliplatin; D017239:Paclitaxel / Q000008:administration & dosage
chemical_list: D000069287:Capecitabine; D003841:Deoxycytidine; D005472:Fluorouracil; D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D017239:Paclitaxel