Phase i trial of docetaxel, oxaliplatin, and capecitabine (DOC) in untreated gastric cancer patients

Sergio Frustaci, Angela Buonadonna, Elisa Turchet, Giuseppe Corona, Gianna Tabaro, Gianmaria Miolo, Elena Torrisi, Giovanni Lo Re, Salvatore Tumolo, Giuseppe Toffoli

Research output: Contribution to journalArticlepeer-review

Abstract

Background: A combination of docetaxel (D), oxaliplatin (O), and capecitabine (C) (DOC) was studied in this dose-escalation phase Ib trial in patients with untreated advanced gastric cancer. Methods: Dose-limiting toxicity (DLT) included any grade 4 hematological or any grade 3 non-hematological toxicity, besides alopecia and nausea or vomiting. Cohorts of three patients, expanded to six if one DLT occurred, were studied. Two DLTs out of three patients, or ≥3 out of six patients defined the toxic level. The preceding level, maximum tolerated dose (MTD), was further expanded to nine patients. The primary objective was to establish the MTD of the DOC regimen. Results: Twenty-one patients entered four dose levels. Levels I, II, and IIb were considered safe and included 3, 6, and 6 patients, respectively. Level III defined our toxic level with three analyzed patients. Therefore, level IIB was expanded to 9 patients. No other DLTs were recorded. Conclusions: Fractionation of doses and the use of less toxic and more convenient derivatives are the rationales for this new combination. The MTD (mg/m2) was: D, 30 and O, 70, both on days 1 and 8, i.v.; C 1000 per day, days 2-15, p.o.; all given every 3 weeks. A cooperative phase II study has been opened.

Original languageEnglish
Pages (from-to)510-516
Number of pages7
JournalInternational Journal of Clinical Oncology
Volume18
Issue number3
DOIs
Publication statusPublished - Jun 2013

Keywords

  • Chemotherapy
  • DOC regimen
  • Pharmacokinetic
  • Phase I

ASJC Scopus subject areas

  • Oncology
  • Surgery
  • Hematology

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