A Multicenter, Open-Label, Two-Stage, Phase II Study Of PS-341 (LDP-341, NSC # 681239) In Patients With Unresectable Or Metastatic Gastric Adenocarcinoma
- Determine the efficacy of bortezomib in patients with unresectable or metastatic
gastric or gastroesophageal junction adenocarcinoma.
- Determine the toxicity of this drug in these patients.
- Determine possible predictors of response to this drug, using pretreatment tumor
immunohistochemistry, in these patients.
OUTLINE: This is an open-label, nonrandomized, multicenter study.
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat
every 3 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year.
PROJECTED ACCRUAL: A total of 15-33 patients will be accrued for this study within 5-12
Masking: Open Label, Primary Purpose: Treatment
Manish A. Shah, MD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|
|University of Chicago Cancer Research Center||Chicago, Illinois 60637|
|University of Wisconsin Comprehensive Cancer Center||Madison, Wisconsin 53792|
|Queens Cancer Center of Queens Hospital||Jamaica, New York 11432|