title: Capecitabine, oxaliplatin and radiotherapy: a phase IB neoadjuvant study for esophageal cancer with gene expression analysis.
abstract: OBJECTIVE
  To determine the maximal tolerated dose of capecitabine with oxaliplatin + radiotherapy in a phase I study of localized esophageal cancer.
  
  
  METHODS
  Oxaliplatin (85 mg/m(2)) administered on days 1, 15, and 29. Capecitabine administered twice daily 5 days weekly; dose levels (DL) were 1, 1000; 2, 1250; and 3, 1500 mg/m(2) with 50.4 Gy radiation.
  
  
  RESULTS
  Dose-limiting toxicity was reached at DL 3. Carboxylesterase expression in day 2 tumor specimens and induction correlated with response (p <or= 0.05).
  
  
  CONCLUSIONS
  The maximal tolerated dose was 85 mg/m(2) of oxaliplatin, 1,250 mg/m(2)/day of capecitabine, and 50.4 Gy of radiation.
authors.affiliation: Department of Gastrointestinal Medical Oncology, UT-MD Anderson Cancer Institute, Houston, Texas, USA. mjavle@mdanderson.org
authors.forename: Milind M
authors.initials: MM
authors.lastname: Javle
authors.forename: Gary
authors.initials: G
authors.lastname: Yang
authors.forename: Chumy E
authors.initials: CE
authors.lastname: Nwogu
authors.forename: Gregory E
authors.initials: GE
authors.lastname: Wilding
authors.forename: Linda
authors.initials: L
authors.lastname: O'Malley
authors.forename: Sanjay
authors.initials: S
authors.lastname: Vinjamaram
authors.forename: Michael D
authors.initials: MD
authors.lastname: Schiff
authors.forename: Hector R
authors.initials: HR
authors.lastname: Nava
authors.forename: Charles
authors.initials: C
authors.lastname: LeVea
authors.forename: Kimberly R
authors.initials: KR
authors.lastname: Clark
authors.forename: Joshua D
authors.initials: JD
authors.lastname: Prey
authors.forename: Patrick F
authors.initials: PF
authors.lastname: Smith
authors.forename: Lakshmi
authors.initials: L
authors.lastname: Pendyala
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D000069287:Capecitabine; D043182:Carboxylesterase / Q000235:genetics; D003131:Combined Modality Therapy; D003564:Cytidine Deaminase / Q000235:genetics; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives / Q000493:pharmacokinetics; D004938:Esophageal Neoplasms / Q000378:metabolism / Q000628:therapy*; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives / Q000493:pharmacokinetics; D006801:Humans; D008297:Male; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics; D000077150:Oxaliplatin; D013939:Thymidine Phosphorylase / Q000235:genetics
chemical_list: D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D003841:Deoxycytidine; D000069287:Capecitabine; D013939:Thymidine Phosphorylase; D043182:Carboxylesterase; D003564:Cytidine Deaminase; D005472:Fluorouracil