Bortezomib in Treating Patients With Unresectable or Metastatic Gastric Cancer or Gastroesophageal Junction Adenocarcinoma
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|ClinicalTrials.gov Identifier: NCT00074009|
Recruitment Status : Completed
First Posted : December 11, 2003
Last Update Posted : February 14, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Gastric Cancer||Drug: bortezomib||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Masking:||None (Open Label)|
|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|
|Actual Primary Completion Date :||April 2005|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00074009
|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|