A phase I study of docetaxel, oxaliplatin, & capecitabine (DOC) as first-line therapy of patients with locally advanced or metastatic adenocarcinoma of stomach and GE junction

Cancer Invest. 2010 Oct;28(8):833-8. doi: 10.3109/07357901003630942.

Abstract

Purpose: We conducted a phase I trial of chemotherapy in patients with advanced gastro-esophageal cancer.

Methods: Eligible patients had chemotherapy doses increased until dose limiting toxicity (DLT) was observed.

Results: Fourteen patients were accrued. No DLT was observed in first three patients at level 1. DLT was observed in two out of five patients at level 2. Six additional patients were treated at level 1.

Conclusions: Recommended doses for future trials are: docetaxel 30 mg/m(2) and oxaliplatin 50 mg/m(2) on days 1 and 8 and capecitabine 675 mg/m(2) PO, bid, on days 1-14 on a three weekly basis.

Publication types

  • Clinical Trial, Phase I
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adenocarcinoma / drug therapy*
  • Adenocarcinoma / pathology
  • Adult
  • Aged
  • Antimetabolites, Antineoplastic / administration & dosage
  • Antimetabolites, Antineoplastic / toxicity
  • Antineoplastic Combined Chemotherapy Protocols / toxicity*
  • Capecitabine
  • Deoxycytidine / administration & dosage
  • Deoxycytidine / analogs & derivatives
  • Deoxycytidine / toxicity
  • Diarrhea / chemically induced
  • Docetaxel
  • Dose-Response Relationship, Drug
  • Drug Administration Schedule
  • Esophageal Neoplasms / drug therapy*
  • Esophageal Neoplasms / pathology
  • Fatigue / chemically induced
  • Fluorouracil / administration & dosage
  • Fluorouracil / analogs & derivatives
  • Fluorouracil / toxicity
  • Humans
  • Male
  • Middle Aged
  • Nausea / chemically induced
  • Neoplasm Staging
  • Organoplatinum Compounds / administration & dosage
  • Organoplatinum Compounds / toxicity
  • Oxaliplatin
  • Stomach Neoplasms / drug therapy*
  • Stomach Neoplasms / pathology
  • Taxoids / administration & dosage
  • Taxoids / toxicity
  • Vomiting / chemically induced

Substances

  • Antimetabolites, Antineoplastic
  • Organoplatinum Compounds
  • Taxoids
  • Oxaliplatin
  • Deoxycytidine
  • Docetaxel
  • Capecitabine
  • Fluorouracil