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

Overview

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/m). 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.

publication date

  • February 1, 2010

Research

keywords

  • Antineoplastic Combined Chemotherapy Protocols
  • Esophageal Neoplasms
  • Esophagogastric Junction
  • Oligonucleotides, Antisense
  • Stomach Neoplasms
  • Thionucleotides

Identity

PubMed Central ID

  • PMC3555559

Scopus Document Identifier

  • 76749168019

Digital Object Identifier (DOI)

  • 10.1097/COC.0b013e3181a31ad0

PubMed ID

  • 19738454

Additional Document Info

volume

  • 33

issue

  • 1