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Status:

TERMINATED

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

Lead Sponsor:

California Cancer Consortium

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Gastric Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE2

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...

Detailed Description

OBJECTIVES: Primary * Determine response in patients with previously treated metastatic or unresectable gastric or gastroesophageal junction adenocarcinoma treated with bortezomib, fluorouracil, and...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • 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
  • PATIENT CHARACTERISTICS:
  • Age
  • Over 18
  • Performance status
  • ECOG 0-2 OR
  • Karnofsky 60-100%
  • Life expectancy
  • At least 3 months
  • Hematopoietic
  • Absolute neutrophil count ≥ 1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • Hepatic
  • Bilirubin normal
  • AST and ALT ≤ 2.5 times upper limit of normal
  • Renal
  • Creatinine ≤ 1.5 mg/dL
  • Cardiovascular
  • 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
  • Other
  • 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
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • More than 4 weeks since prior immunotherapy
  • Chemotherapy
  • More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
  • Endocrine therapy
  • Not specified
  • Radiotherapy
  • More than 4 weeks since prior radiotherapy and recovered
  • Surgery
  • More than 2 weeks since prior major surgery
  • Other
  • No concurrent highly active anti-retroviral therapy for HIV-positive patients
  • No other concurrent investigational agents

Exclusion

    Key Trial Info

    Start Date :

    March 1 2005

    Trial Type :

    INTERVENTIONAL

    End Date :

    August 1 2005

    Estimated Enrollment :

    Patients enrolled

    Trial Details

    Trial ID

    NCT00103103

    Start Date

    March 1 2005

    End Date

    August 1 2005

    Last Update

    October 13 2010

    Active Locations (5)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (5 locations)

    1

    City of Hope Comprehensive Cancer Center

    Duarte, California, United States, 91010-3000

    2

    USC/Norris Comprehensive Cancer Center and Hospital

    Los Angeles, California, United States, 90089-9181

    3

    City of Hope Medical Group

    Pasadena, California, United States, 91105

    4

    University of California Davis Cancer Center

    Sacramento, California, United States, 95817