Bortezomib in Treating Patients With Unresectable or Metastatic Gastric Cancer or Gastroesophageal Junction Adenocarcinoma
RATIONALE: Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for their growth.
PURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who have unresectable or metastatic gastric cancer or gastroesophageal junction adenocarcinoma.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Multicenter, Open-Label, Two-Stage, Phase II Study Of PS-341 (LDP-341, NSC # 681239) In Patients With Unresectable Or Metastatic Gastric Adenocarcinoma|
|Study Start Date:||October 2003|
|Primary Completion Date:||April 2005 (Final data collection date for primary outcome measure)|
- 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 months.
|United States, Illinois|
|University of Chicago Cancer Research Center|
|Chicago, Illinois, United States, 60637-1470|
|United States, New York|
|Queens Cancer Center of Queens Hospital|
|Jamaica, New York, United States, 11432|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|United States, Wisconsin|
|University of Wisconsin Comprehensive Cancer Center|
|Madison, Wisconsin, United States, 53792-3236|
|Principal Investigator:||Manish A. Shah, MD||Memorial Sloan-Kettering Cancer Center|
|Principal Investigator:||Gary K. Schwartz, MD||Memorial Sloan-Kettering Cancer Center|