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CompletedNCT00074009Updated Feb 14, 2012

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

A Phase 2 interventional study of bortezomib in Gastric Cancer, sponsored by Memorial Sloan Kettering Cancer Center. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-02-14.

Sponsored by Memorial Sloan Kettering Cancer Center · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the efficacy of bortezomib in patients with unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.

Secondary

  • 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.

02

Conditions studied

  • Gastric Cancer

Keywords

  • recurrent gastric cancer
  • stage III gastric cancer
  • stage IV gastric cancer
  • adenocarcinoma of the stomach
03

In context

Adenocarcinoma

2,004 studies on the registry are indexed under Adenocarcinoma; 374 are open to participants now.

Browse Adenocarcinoma studies →

Lead sponsor

Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,930 studies on the registry; 328 are open to participants now.

Of its 128 completed or terminated interventional studies of FDA-regulated products, 66 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Karnofsky 60-100% OR
  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

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

Hepatic

  • 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)

Renal

  • Creatinine no greater than 1.5 mg/dL

Cardiovascular

  • 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

Other

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

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

Chemotherapy

  • 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

Radiotherapy

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

Surgery

  • Not specified

Other

  • Recovered from all prior therapy
  • No other concurrent investigational agents
  • No other concurrent anticancer agent or therapy
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Masking
None (open label)

Interventions

  • Drugbortezomib
06

Study locations

4 sites
  • University of Chicago Cancer Research Center
    Chicago, Illinois 60637-1470, United States
  • Queens Cancer Center of Queens Hospital
    Jamaica, New York 11432, United States
  • Memorial Sloan-Kettering Cancer Center
    New York, New York 10021, United States
  • University of Wisconsin Comprehensive Cancer Center
    Madison, Wisconsin 53792-3236, United States
07

References and documents

Publications

  • Shah MA, Power DG, Kindler HL, Holen KD, Kemeny MM, Ilson DH, Tang L, Capanu M, Wright JJ, Kelsen DP. A multicenter, phase II study of bortezomib (PS-341) in patients with unresectable or metastatic gastric and gastroesophageal junction adenocarcinoma. Invest New Drugs. 2011 Dec;29(6):1475-81. doi: 10.1007/s10637-010-9474-7. Epub 2010 Jun 25. PubMed 20574790 ↗
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 14, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00074009
Lead sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
First posted
Dec 11, 2003
Start date
Oct 2003
Primary completion
Apr 2005
Last update
Feb 14, 2012

Study contacts

Manish A. Shah, MD
principal investigator · Memorial Sloan Kettering Cancer Center
Gary K. Schwartz, MD
principal investigator · Memorial Sloan Kettering Cancer Center
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2009. You cannot join it, but the record below documents what was studied.

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