title: A triplet chemotherapy with cisplatin, docetaxel and gemcitabine in patients with advanced non-small-cell lung cancer: a phase I/II study.
abstract: OBJECTIVE
  We conducted a phase I/II study of triplet chemotherapy consisting of cisplatin (CDDP), docetaxel (DCT) and gemcitabine (GEM) in patients with advanced non-small-cell lung cancer (NSCLC).
  
  
  METHODS
  Fifty-three untreated patients with stage IIIB or IV NSCLC were enrolled. All drugs were given on days 1 and 8. The doses of CDDP and DCT were fixed at 40 mg/m(2) and 30 mg/m(2), respectively. In the phase I portion, a dose escalation study of GEM with starting dose of 400 mg/m(2) was conducted and primary objective in the phase II portion was response rate.
  
  
  RESULTS
  The maximally tolerated dose (MTD) and recommended dose (RD) of GEM were determined as 800 mg/m(2) because grade 3 non-hematological toxicity (liver damage, diarrhea, and fatigue) developed in three of nine patients evaluated at that dose level. In pharmacokinetic analysis, C (max) and AUC of dFdC and dFdU were increased along with the dose escalation of GEM. However, no relationship between pharmacokinetic parameters and toxicity or response was observed. Objective response rate was 34% and median survival time was 11.7 months. Though major toxicity was myelosuppression, there were no life-threatening toxicities.
  
  
  CONCLUSIONS
  These results indicate that this triplet chemotherapy is feasible and effective in patients with advanced NSCLC.
authors.affiliation: Department of Respiratory Medicine, Okayama University Hospital, Okayama, Japan.
authors.forename: Masahiro
authors.initials: M
authors.lastname: Tabata
authors.forename: Toshiyuki
authors.initials: T
authors.lastname: Kozuki
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Ueoka
authors.forename: Katsuyuki
authors.initials: K
authors.lastname: Kiura
authors.forename: Shingo
authors.initials: S
authors.lastname: Harita
authors.forename: Atsuhiko
authors.initials: A
authors.lastname: Tada
authors.forename: Takuo
authors.initials: T
authors.lastname: Shibayama
authors.forename: Nagio
authors.initials: N
authors.lastname: Takigawa
authors.forename: Toshiro
authors.initials: T
authors.lastname: Yonei
authors.forename: Kenichi
authors.initials: K
authors.lastname: Gemba
authors.forename: Yoshihiko
authors.initials: Y
authors.lastname: Segawa
authors.forename: Daizo
authors.initials: D
authors.lastname: Kishino
authors.forename: Shinya
authors.initials: S
authors.lastname: Tada
authors.forename: Shunkichi
authors.initials: S
authors.lastname: Hiraki
authors.forename: Mitsune
authors.initials: M
authors.lastname: Tanimoto
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D019540:Area Under Curve; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives / Q000493:pharmacokinetics; D000077143:Docetaxel; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D007970:Leukopenia / Q000139:chemically induced; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008657:Metabolic Clearance Rate; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D009364:Neoplasm Recurrence, Local; D009367:Neoplasm Staging; D011247:Pregnancy; D016019:Survival Analysis; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics; D016896:Treatment Outcome; D014839:Vomiting / Q000139:chemically induced; D000093542:Gemcitabine
chemical_list: D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D002945:Cisplatin; D000093542:Gemcitabine