title: A phase I/II trial of docetaxel and oxaliplatin in patients with advanced gastric cancer.
abstract: OBJECTIVE
  We designed this phase I/II study of docetaxel-oxaliplatin combination chemotherapy to determine the dose-limiting toxicity (DLT), maximum tolerated dose and efficacy as a first-line treatment in patients with advanced gastric cancer.
  
  
  METHODS
  Patients with histologically proven, chemo-naive gastric adenocarcinoma were eligible. For the phase I part, three dose levels of oxaliplatin and docetaxel every 3 weeks were tested in a cohort of three patients for each level (respectively, 100 and 60 mg/m(2), 100 and 75 mg/m(2), 130 and 75 mg/m(2)). Patients were treated up to a maximum of nine cycles of oxaliplatin and docetaxel unless there was documented disease progression, an unacceptable adverse event, or withdrawal of consent.
  
  
  RESULTS
  No DLT was observed at any of the three levels tested in the phase I portion. Therefore, oxaliplatin 130 mg/m(2) and docetaxel 75 mg/m(2) were recommended for the phase II study. All 47 patients were evaluable for toxicity and treatment response. The overall response rate was 55.3% (95% CI, 40.6-70.1%) and median duration of response was 4.2 months (range 0.9-9.5 months). After a median follow-up duration of 13.3 months, median overall survival was 12.7 months (95% CI: 10.4-14.9). The median time to progression was 5.0 months (95% CI, 3.4-6.5 months). The main toxicities (grade 3 or 4) were febrile neutropenia (14.9%), neutropenia (23.4%), diarrhea (10.6%) and neurotoxicity (8.5%).
  
  
  CONCLUSIONS
  The combination of docetaxel and oxaliplatin was feasible with favorable toxicity profile and showed a promising anti-tumor activity in unresectable, metastatic gastric cancer patients.
authors.affiliation: Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 50 Ilwon-dong Kangnam-gu, Seoul, 135-710, South Korea.
authors.forename: Kyoung Ha
authors.initials: KH
authors.lastname: Kim
authors.forename: Young Suk
authors.initials: YS
authors.lastname: Park
authors.forename: Myung Hee
authors.initials: MH
authors.lastname: Chang
authors.forename: Hyo Song
authors.initials: HS
authors.lastname: Kim
authors.forename: Hyun Jung
authors.initials: HJ
authors.lastname: Jun
authors.forename: Jieun
authors.initials: J
authors.lastname: Uhm
authors.forename: Seong Yoon
authors.initials: SY
authors.lastname: Yi
authors.forename: Do Hyoung
authors.initials: DH
authors.lastname: Lim
authors.forename: Sang Hoon
authors.initials: SH
authors.lastname: Ji
authors.forename: Min Jae
authors.initials: MJ
authors.lastname: Park
authors.forename: Jeeyun
authors.initials: J
authors.lastname: Lee
authors.forename: Se Hoon
authors.initials: SH
authors.lastname: Park
authors.forename: Joon Oh
authors.initials: JO
authors.lastname: Park
authors.forename: Ho Yeong
authors.initials: HY
authors.lastname: Lim
authors.forename: Won Ki
authors.initials: WK
authors.lastname: Kang
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000556:secondary; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D000077143:Docetaxel; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008207:Lymphatic Metastasis; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009367:Neoplasm Staging; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D000077150:Oxaliplatin; D011379:Prognosis; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000473:pathology; D015996:Survival Rate; D043823:Taxoids / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D009944:Organoplatinum Compounds; D043823:Taxoids; D000077150:Oxaliplatin; D000077143:Docetaxel