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Status:

COMPLETED

Bortezomib in Treating Patients With Advanced Cancer and Liver Dysfunction

Lead Sponsor:

National Cancer Institute (NCI)

Conditions:

Hepatic Complications

Malignant Neoplasm

Eligibility:

All Genders

18+ years

Phase:

PHASE1

Brief Summary

Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for their growth. This phase I trial is studying the side effects and best dose of bortezomib in treating patients with...

Detailed Description

PRIMARY OBJECTIVES: I. Determine the maximum tolerated dose of bortezomib in patients with advanced malignancies and varying degrees of liver dysfunction. II. Determine the safety and tolerability o...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • Histologically confirmed malignancy for which no known standard therapy that is potentially curative or definitely capable of extending life expectancy exists
  • Tumor types may include any of the following: solid tumors:
  • Non-Hodgkin's lymphoma
  • Hepatocellular carcinoma, as evidenced by liver mass, elevated alpha-fetoprotein level (\>= 500 ng/mL), and positive serology for hepatitis
  • Pathological confirmation is not required
  • Confirmatory evidence for a prior Hepatitis B infection (HBsAg, HBcAb and/or HBsAb) required
  • No symptomatic CNS metastases
  • Brain metastasis allowed if the following criteria are met:
  • Received prior definitive treatment (radiation and/or surgery
  • Stable disease for \>= 4 weeks
  • Not currently on enzyme-inducing anticonvulsants and steroids
  • Life expectancy of at least 12 weeks
  • Absolute neutrophil count \>= 1,000/mm\^3
  • Platelet count \>= 100,000/mm\^3
  • Biliary obstruction for which a shunt has been placed allowed provided the shunt has been in place for \>= 10 days AND liver function is stable, defined as 2 measurements taken \>= 2 days apart that qualify the patient for the same hepatic dysfunction stratum
  • No biliary sepsis
  • Creatinine =\< 1.5 mg/dL
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • No New York Heart Association class III or IV heart disease
  • Not pregnant or nursing
  • Negative pregnancy test
  • No preexisting neuropathy \>= grade 2
  • No ongoing or active infection
  • No other concurrent uncontrolled illness that would preclude study participation
  • No psychiatric illness or social situation that would preclude study compliance
  • More than 4 weeks since prior immunotherapy
  • More than 4 weeks since prior biologic therapy
  • No concurrent prophylactic colony-stimulating factors
  • No concurrent immunotherapy
  • No concurrent thalidomide
  • Concurrent epoetin alfa or darbepoetin alfa for management of cancer-associated anemia allowed
  • Recovered from prior chemotherapy (not including liver function)
  • More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
  • No concurrent chemotherapy
  • More than 2 weeks since prior radiotherapy
  • No prior radiotherapy to \> 50% of the bone marrow
  • No concurrent radiotherapy
  • More than 3 weeks since prior surgery
  • No prior bortezomib
  • No concurrent antiretroviral therapy for HIV-positive patients
  • No other concurrent investigational agents
  • Concurrent cytochrome P450 interacting agents are allowed provided they are used with caution
  • Concurrent bisphosphonate therapy allowed (e.g., pamidronate or zoledronate), except during course 1 of bortezomib administration
  • ECOG 0-2
  • Fertile patients must use effective contraception during and for 30 days after study participation

Exclusion

    Key Trial Info

    Start Date :

    July 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    80 Patients enrolled

    Trial Details

    Trial ID

    NCT00091117

    Start Date

    July 1 2004

    Last Update

    December 16 2013

    Active Locations (3)

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

    Page 1 of 1 (3 locations)

    1

    City of Hope Medical Center

    Duarte, California, United States, 91010

    2

    Johns Hopkins University

    Baltimore, Maryland, United States, 21287-8936

    3

    Wayne State University

    Detroit, Michigan, United States, 48202