Bortezomib, Fluorouracil, and Leucovorin in Treating Patients With Metastatic or Unresectable Stomach Cancer

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: NCT00103103
Recruitment Status : Terminated
First Posted : February 8, 2005
Last Update Posted : October 13, 2010
National Cancer Institute (NCI)
Information provided by:
California Cancer Consortium

Brief Summary:

RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fluorouracil and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with fluorouracil and leucovorin may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving bortezomib together with fluorouracil and leucovorin works in treating patients with metastatic or unresectable stomach cancer.

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: bortezomib Drug: fluorouracil Drug: leucovorin calcium Phase 2

Detailed Description:



  • Determine response in patients with previously treated metastatic or unresectable gastric or gastroesophageal junction adenocarcinoma treated with bortezomib, fluorouracil, and leucovorin calcium.


  • Determine time to progression and overall survival of patients treated with this regimen.
  • Determine the toxic effects of this regimen in these patients.

OUTLINE: This is a non-randomized, multicenter study.

Patients receive bortezomib IV over 3-5 seconds on days 1, 8, and 15. One hour after completion of bortezomib, patients receive leucovorin calcium IV and fluorouracil IV followed by fluorouracil IV continuously over 46 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed for survival.

PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study.

Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Combination Trial of PS-341 and 5-FU/LV in Gastric and/or GE Junction Adenocarcinoma
Study Start Date : March 2005
Actual Primary Completion Date : August 2005
Actual Study Completion Date : August 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
U.S. FDA Resources

Primary Outcome Measures :
  1. Response rate as measured by RECIST every 8 weeks

Secondary Outcome Measures :
  1. Time to progression every 8 weeks
  2. Overall survival
  3. Toxicity every 4 weeks
  4. Molecular correlates on and off study treatment

Information from the National Library of Medicine

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


  • Diagnosis of gastric or gastroesophageal junction adenocarcinoma

    • Metastatic or unresectable disease
  • Progressive disease after receiving 1 prior chemotherapy regimen for metastatic disease comprising 1 of the following:

    • Fluorouracil
    • Cisplatin and irinotecan
    • Capecitabine
    • Taxanes
  • Measurable disease
  • No esophageal cancer
  • No brain metastases



  • Over 18

Performance status

  • ECOG 0-2 OR
  • Karnofsky 60-100%

Life expectancy

  • At least 3 months


  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3


  • Bilirubin normal
  • AST and ALT ≤ 2.5 times upper limit of normal


  • Creatinine ≤ 1.5 mg/dL


  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • No acute ischemia by EKG
  • No significant conduction abnormality by EKG, including either of the following:

    • Bifasicular block, defined as left anterior hemiblock in the presence of right bundle branch block
    • Second or third degree atrioventricular block
  • No history of cardiac or cerebrovascular disease due to hypotension and tachycardia


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception before, during, and for 6 months after study participation
  • No ongoing or active infection
  • No other uncontrolled illness
  • No peripheral neuropathy ≥ grade 2 within the past 2 weeks
  • No allergy to boron or mannitol


Biologic therapy

  • More than 4 weeks since prior immunotherapy


  • More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered

Endocrine therapy

  • Not specified


  • More than 4 weeks since prior radiotherapy and recovered


  • More than 2 weeks since prior major surgery


  • No concurrent highly active anti-retroviral therapy for HIV-positive patients
  • No other concurrent investigational agents

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): NCT00103103

United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90089-9181
City of Hope Medical Group
Pasadena, California, United States, 91105
University of California Davis Cancer Center
Sacramento, California, United States, 95817
United States, Pennsylvania
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
California Cancer Consortium
National Cancer Institute (NCI)
Study Chair: Heinz-Josef Lenz, MD University of Southern California Identifier: NCT00103103     History of Changes
Other Study ID Numbers: CDR0000410827
First Posted: February 8, 2005    Key Record Dates
Last Update Posted: October 13, 2010
Last Verified: October 2010

Keywords provided by California Cancer Consortium:
recurrent gastric cancer
stage IV gastric cancer
adenocarcinoma of the stomach

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protective Agents