title: A phase I study of the oral platinum agent satraplatin in sequential combination with capecitabine in the treatment of patients with advanced solid malignancies.
abstract: BACKGROUND
  The broad spectrum of antitumor activity of both the oral platinum analogue satraplatin (S) and capecitabine (C), along with the advantage of their oral administration, prompted a clinical study aimed to define the maximum tolerated dose (MTD) of the combination.
  
  
  METHODS
  Four dose levels of S (mg/m(2)/day) and C (mg/m(2)/day) were evaluated in adult patients with advanced solid tumors: 60/1650, 80/1650, 60/2000, 70/2000; a course consisted of 28 days with sequential administration of S (days 1-5) and C (days 8-21) followed by one week rest.
  
  
  RESULTS
  Thirty-seven patients were treated, 24 in the dose escalation and 13 in the expansion phase; at the MTD, defined at S 70/C 2000, two patients presented dose limiting toxicities: lack of recovery of neutropenia by day 42 and nausea with dose skip of C. Most frequent toxicities were nausea (57%), diarrhea (51%), neutropenia (46%), anorexia, fatigue, vomiting (38% each). Two partial responses were observed in platinum sensitive ovarian cancer and one in prostate cancer.
  
  
  CONCLUSIONS
  At S 70/C 2000 the combination of sequential S and C is tolerated with manageable toxicities; its evaluation in platinum and fluorouracil sensitive tumor types is worthwhile because of the easier administration and lack of nephro- and neurotoxicity as compared to parent compounds.
authors.affiliation: Istituto Oncologico della Svizzera Italiana, Bellinzona, Switzerland.
authors.forename: Elisa
authors.initials: E
authors.lastname: Gallerani
authors.forename: Jean
authors.initials: J
authors.lastname: Bauer
authors.forename: Dagmar
authors.initials: D
authors.lastname: Hess
authors.forename: Steffen
authors.initials: S
authors.lastname: Boehm
authors.forename: Cornelia
authors.initials: C
authors.lastname: Droege
authors.forename: Sandrine
authors.initials: S
authors.lastname: Jeckelmann
authors.forename: Monica
authors.initials: M
authors.lastname: Miani
authors.forename: Richard
authors.initials: R
authors.lastname: Herrmann
authors.forename: Silvia
authors.initials: S
authors.lastname: Marsoni
authors.forename: Sabine
authors.initials: S
authors.lastname: Sperka
authors.forename: Cristiana
authors.initials: C
authors.lastname: Sessa
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage* / Q000009:adverse effects; D000069287:Capecitabine; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D003967:Diarrhea / Q000139:chemically induced; D018450:Disease Progression; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005221:Fatigue / Q000139:chemically induced; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D006801:Humans; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D009369:Neoplasms / Q000188:drug therapy* / Q000473:pathology; D009503:Neutropenia / Q000139:chemically induced; D009944:Organoplatinum Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D014839:Vomiting / Q000139:chemically induced
chemical_list: D000964:Antimetabolites, Antineoplastic; D009944:Organoplatinum Compounds; D003841:Deoxycytidine; D000069287:Capecitabine; C081294:satraplatin; D005472:Fluorouracil