A Phase I/II Study of Oblimersen Plus Cisplatin and Fluorouracil in Gastric & Esophageal Junction Cancer

Phase 1/2 Terminated 15 enrolled National Cancer Institute (NCI)

NaSingle-groupOpen-labelTreatment

Summary

Drugs used in chemotherapy such as cisplatin and fluorouracil use different ways to stop tumor cells from dividing so they stop growing or die. Oblimersen may increase the effectiveness of chemotherapy by making tumor cells more sensitive to the drugs. This phase I/II trial is studying the side effects and best dose of oblimersen when given with cisplatin and fluorouracil and to see how well they work in treating patients with locally advanced, recurrent, or metastatic cancer of the esophagus, gastroesophageal junction, or stomach.

Timeline

Start: 2003-06
Primary completion: 2010-02
Completion: 2010-02

Publications

Results Raab R, Sparano JA, Ocean AJ, Christos P, Ramirez M, Vinciguerra V, Kaubisch A. A phase I trial of oblimersen sodium in combination with cisplatin and 5-fluorouracil in patients with advanced esophageal, gastroesophageal junction, and gastric carcinoma. Am J Clin Oncol. 2010 Feb;33(1):61-5. doi: 10.1097/COC.0b013e3181a31ad0.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cisplatin	Other / unclassified	75 mg/m2	Intravenous
Subject	Cisplatin	Other / unclassified	100 mg/m2	Intravenous
Subject	fluorouracil	Small molecule	750 mg/m2	Intravenous
Subject	fluorouracil	Small molecule	1000 mg/m2	Intravenous
Subject	oblimersen sodium	Antisense oligonucleotide	3 mg/kg	Intravenous
Subject	oblimersen sodium	Antisense oligonucleotide	5 mg/kg	Intravenous
Subject	oblimersen sodium	Antisense oligonucleotide	7 mg/kg	Intravenous

A Phase I/II Study of Oblimersen Plus Cisplatin and Fluorouracil in Gastric & Esophageal Junction Cancer

Summary

Timeline

Publications

Drugs

Indications