A phase I trial of oblimersen sodium in combination with cisplatin and 5-fluorouracil in patients with advanced esophageal, gastroesophageal junction, and gastric carcinoma

Rachel Raab, Joseph A. Sparano, Allyson J. Ocean, Paul Christos, Mark Ramirez, Vincent Vinciguerra, Andreas Kaubisch

Research output: Contribution to journalArticle

10 Scopus citations

Abstract

Purpose: To determine the maximum tolerated dose of oblimersen, an antisense oligonucleotide directed to the Bcl-2 mRNA, in combination with cisplatin and 5-flourouracil in patients with advanced gastric and esophageal carcinoma. Methods: Patients were treated with escalating doses of oblimersen administered by continuous intravenous infusion (CIVI) days 1 to 7, CIVI 5-fluorouracil (5-FU) days 4 to 7, and cisplatin on day 4 every 3 weeks. Results: Fifteen patients received a total of 49 courses of oblimersen at doses of 3, 5, or 7 mg/kg/d given as a 7 day CIVI in combination with 4 or 5 day CIVI of 5-FU (1000 or 750 mg/m2/d) plus intravenous cisplatin (100 or 75 mg/m2 over 2 hours). The recommended phase II dose of oblimersen was 5 mg/kg/d in combination with 5-FU (750 mg/m2/d for 4 days) and cisplatin (75 mg/m2). The most common grade 3 to 4 adverse events that occurred in at least 10% of patients at all dose levels included neutropenia (33%), hypokalemia (27%), infection (20%), and mucositis, fatigue, dizziness, thrombosis, and dehydration (in 13% for each category). Conclusion: The combination of oblimersen with 5-FU and cisplatin chemotherapy is feasible in patients with advanced upper gastrointestinal cancer, with antitumor activity observed in gastric carcinoma.

Original languageEnglish (US)
Pages (from-to)61-65
Number of pages5
JournalAmerican Journal of Clinical Oncology: Cancer Clinical Trials
Volume33
Issue number1
DOIs
StatePublished - Feb 1 2010

Keywords

  • BCL-2
  • Gastric cancer
  • Gastroesophageal cancer
  • Oblimersen

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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