title: A phase I study of the oral platinum agent satraplatin in combination with oral vinorelbine in patients with advanced solid malignancies.
abstract: BACKGROUND
  The broad spectrum of antitumor activity of the oral platinum satraplatin (S) and vinorelbine (V) were the rationale for performing a phase I trial to define the maximum tolerated (MTD) and the recommended (RD) dose in adult patients with advanced solid tumors.
  
  
  METHODS
  4 dose levels (DLs) of S (mg/m(2)/day, days 1-5) and V (mg/m(2)/day, days 1, 8, 15, and 22) every 28 days were explored: S60/V60 on days 1, 8 and 15 only; S60/V60; S70/V60; and S80/V60. Subsequently, 3 further DLs were evaluated with V omitted on day 22: S70/V60, S80/V60, and S80/V80.
  
  
  RESULTS
  Treating 27 patients, the MTD was S80/V80 on days 1, 8, and 15, with 2 dose-limiting toxicities in 2 patients (nausea and vomiting grade (G) 3 with skipping of V on day 15, and neutropenia G4 with infection). The RD was S80/V60 on days 1, 8, and 15. The most frequent toxicities (any G) were nausea (70%), diarrhea (59%), anorexia (37%), vomiting (33%), asthenia (26%), constipation (26%), and paresthesia (18%). Partial responses were observed in 2 platinum-sensitive ovarian cancer patients and in 1 prostate cancer patient.
  
  
  CONCLUSIONS
  The combination of S and V is tolerable at a DL of S80/V60 on days 1, 8, and 15; further evaluations in platinum- and V-sensitive tumor types would be of interest.
authors: Istituto Oncologico della Svizzera Italiana, Bellinzona, Switzerland. gallerani.elisa@gmail.com
authors: Elisa
authors: E
authors: Gallerani
authors: Richard
authors: R
authors: Cathomas
authors: Cristiana
authors: C
authors: Sessa
authors: Tiziana
authors: T
authors: Digena
authors: Anna Amalia
authors: AA
authors: Bartosek
authors: Laura
authors: L
authors: Dal Zotto
authors: Roger
authors: R
authors: von Moos
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects; D004305:Dose-Response Relationship, Drug; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced*; D009369:Neoplasms / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy*; D009944:Organoplatinum Compounds / Q000008:administration & dosage* / Q000009:adverse effects*; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000077235:Vinorelbine; D014839:Vomiting / Q000139:chemically induced*
chemical_list: D000970:Antineoplastic Agents; D004338:Drug Combinations; D009944:Organoplatinum Compounds; D014747:Vinblastine; C081294:satraplatin; D000077235:Vinorelbine