Bortezomib in Treating Patients With Unresectable or Metastatic Gastric Cancer or Gastroesophageal Junction Adenocarcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00074009
Recruitment Status : Completed
First Posted : December 11, 2003
Last Update Posted : February 14, 2012
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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

Detailed Description:



  • 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)
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
Actual Primary Completion Date : April 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
Drug Information available for: Bortezomib

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma

    • Siewert's class II or III disease
  • Measurable disease

    • At least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
  • No history of known or active brain metastases or primary brain tumors



  • 18 and over

Performance status

  • Karnofsky 60-100% OR
  • ECOG 0-2

Life expectancy

  • Not specified


  • WBC at least 3,000/mm^3
  • Absolute neutrophil count at least 1,000/mm^3
  • Platelet count at least 100,000/mm^3


  • Bilirubin no greater than 1.5 mg/dL
  • AST and ALT no greater than 3 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)


  • Creatinine no greater than 1.5 mg/dL


  • No prior cerebrovascular event
  • No prior orthostatic hypotension
  • No myocardial infarction within the past 6 months
  • No peripheral vascular disease requiring surgical management
  • No evidence of acute ischemia or significant conduction abnormality by EKG


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for at least 2 months after study participation
  • No evidence of peripheral neuropathy
  • No prior allergic reaction attributed to compounds of similar chemical or biological composition to bortezomib
  • No other malignancy within the past 3 years except basal cell skin cancer, carcinoma in situ of the cervix, or adequately treated nonmetastatic prostate cancer
  • No ongoing or active infection
  • No psychiatric illness or social situation that would preclude study participation
  • No other concurrent uncontrolled illness that would preclude study participation
  • No other medical condition or reason that would preclude study participation


Biologic therapy

  • More than 3 weeks since prior immunotherapy
  • No concurrent biological or immunological agents


  • No more than 1 prior chemotherapy regimen (including adjuvant chemotherapy)
  • More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
  • No concurrent chemotherapy

Endocrine therapy

  • Not specified


  • More than 3 weeks since prior radiotherapy
  • No concurrent radiotherapy


  • Not specified


  • Recovered from all prior therapy
  • No other concurrent investigational agents
  • No other concurrent anticancer agent or therapy

Information from the National Library of Medicine

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 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
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Manish A. Shah, MD Memorial Sloan Kettering Cancer Center
Principal Investigator: Gary K. Schwartz, MD Memorial Sloan Kettering Cancer Center

Publications of Results: Identifier: NCT00074009     History of Changes
Other Study ID Numbers: CDR0000341565
First Posted: December 11, 2003    Key Record Dates
Last Update Posted: February 14, 2012
Last Verified: December 2009

Keywords provided by National Cancer Institute (NCI):
recurrent gastric cancer
stage III gastric cancer
stage IV gastric cancer
adenocarcinoma of the stomach

Additional relevant MeSH terms:
Stomach Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Antineoplastic Agents