NCT00091117

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 advanced cancer and liver dysfunction.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P75+ for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 8, 2004

Completed
8.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Last Updated

December 16, 2013

Status Verified

December 1, 2013

Enrollment Period

8.7 years

First QC Date

September 7, 2004

Last Update Submit

December 13, 2013

Conditions

Hepatic ComplicationsMalignant Neoplasm

Outcome Measures

Primary Outcomes (2)

  • DLT

    21 days

  • MTD

    21 days

Study Arms (1)

Treatment

EXPERIMENTAL

Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Drug: bortezomibOther: pharmacological study

Interventions

bortezomibDRUG

Given IV

Also known as: LDP 341, MLN341, VELCADE
Treatment
pharmacological studyOTHER

Correlative studies

Also known as: pharmacological studies
Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +32 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287-8936, United States

Location

Wayne State University

Detroit, Michigan, 48202, United States

Location

Related Publications (1)

  • LoRusso PM, Venkatakrishnan K, Ramanathan RK, Sarantopoulos J, Mulkerin D, Shibata SI, Hamilton A, Dowlati A, Mani S, Rudek MA, Takimoto CH, Neuwirth R, Esseltine DL, Ivy P. Pharmacokinetics and safety of bortezomib in patients with advanced malignancies and varying degrees of liver dysfunction: phase I NCI Organ Dysfunction Working Group Study NCI-6432. Clin Cancer Res. 2012 May 15;18(10):2954-63. doi: 10.1158/1078-0432.CCR-11-2873. Epub 2012 Mar 6.

    PMID: 22394984DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

Bortezomib

Intervention Hierarchy (Ancestors)

Boronic AcidsAcids, NoncarboxylicAcidsInorganic ChemicalsBoron CompoundsOrganic ChemicalsPyrazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Patricia LoRusso

    Wayne State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2004

First Posted

September 8, 2004

Study Start

July 1, 2004

Primary Completion

March 1, 2013

Last Updated

December 16, 2013

Record last verified: 2013-12

Locations

US(3)