A Phase I/II Study of Docetaxel, Oxaliplatin, and Fluorouracil (D-FOX) Chemotherapy in Patients with Untreated Locally Unresectable or Metastatic Adenocarcinoma of the Stomach and Gastroesophageal Junction

Mariela A.Blum Murphy, Wei Qiao, Nishith Mewada, Roopma Wadhwa, Elena Elimova, Taketa Takashi, Linus Ho, Alexandria Phan, Jackie Baker, Jaffer Ajani

Research output: Contribution to journalArticle

7 Scopus citations

Abstract

Background: A randomized phase III study established docetaxel, cisplatin, and 5-fluorouracil (DCF) as one of the standard treatments for patients with untreated advanced gastric cancer (AGC). However, DCF use is limited due toxicity. With the purpose to evaluate a less toxic regimen, we conducted a single arm, phase I/II trial of modified DCF (oxaliplatin, 5-fluorouracil, and docetaxel [D-FOX]) for untreated AGC patients. The primary objective of the phase I study was to determine the maximum tolerated dose of docetaxel and for the phase II study was to assess the progression-free survival (PFS) at 6 months and overall survival (OS). Patients and Methods: We enrolled a total of 98 patients with AGC. Docetaxel and oxaliplatin were administered intravenously on day 1 and 5-fluorouracil was infused starting on day 1 over 48 hours. Cycles were repeated every 2 weeks and patients were monitored for toxicities. Kaplan-Meir curve was used to estimate unadjusted OS and PFS. Results: The maximum tolerated dose of docetaxel was 50 mg/m2. In total, 24 (45%) patients experienced grade 2 adverse events, 22 (41%) experienced grade 3, and 1 (1.9%) experienced grade 4 toxicity. The median PFS in the phase II portion of the study was approximately 6.5 (95% confidence interval, 5.5-9.5) months and the median OS was 11.1 (95% confidence interval, 9.4-18.8) months. Conclusions: D-FOX administered every 2 weeks is a well-Tolerated and active regimen in untreated AGC patients.

Original languageEnglish (US)
Pages (from-to)321-325
Number of pages5
JournalAmerican Journal of Clinical Oncology: Cancer Clinical Trials
Volume41
Issue number4
DOIs
StatePublished - 2018
Externally publishedYes

Keywords

  • docetaxel
  • fluoropyrimidines
  • gastric cancer
  • oxaliplatin

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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