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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00074009
First received: December 10, 2003
Last updated: February 11, 2012
Last verified: December 2009

December 10, 2003
February 11, 2012
October 2003
April 2005   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00074009 on ClinicalTrials.gov Archive Site
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Bortezomib in Treating Patients With Unresectable or Metastatic Gastric Cancer or Gastroesophageal Junction Adenocarcinoma
A Multicenter, Open-Label, Two-Stage, Phase II Study Of PS-341 (LDP-341, NSC # 681239) In Patients With Unresectable Or Metastatic Gastric 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.

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.

Interventional
Phase 2
Masking: Open Label
Primary Purpose: Treatment
Gastric Cancer
Drug: bortezomib
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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April 2005   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00074009
CDR0000341565, MSKCC-03101, NCI-6003
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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
National Cancer Institute (NCI)
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP