CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 42 enrolled
Drug / intervention
doxorubicin +1 moredrug
Likely dose
Bortezomib IV and doxorubicin IV (specific doses not stated)AI-extracted
Key inclusion· 9
  • ✓Microscopically confirmed hepatocellular carcinoma not amenable to curative resection
  • ✓Measurable disease by RECIST criteria, amenable to biopsy
  • ✓ECOG performance status 0-2
  • ✓No prior systemic chemotherapy for HCC; off other antineoplastics (e.g., methotrexate) for ≥4 weeks
Key exclusion· 7
  • ✕Baseline peripheral neuropathy grade >1
  • ✕Prior octreotide or tamoxifen as therapy for HCC
  • ✕Known allergy to boron, mannitol, or bortezomib
  • ✕History of untreated malignancy other than HCC

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00083226
NCT00083226Phase 2Completed
CompareCT.gov

A Phase II Trial of Bortezomib Plus Doxorubicin in Hepatocellular Carcinoma

National Cancer Institute (NCI)·interventional·Posted May 17, 2004·Updated Oct 30, 2014

In Brief

A Phase 2 clinical trial evaluating doxorubicin and bortezomib for Adult Primary Hepatocellular Carcinoma and 3 related conditions. Completed, enrolled 42 participants across 1 site.

Detailed Summary

This phase II trial is studying how well giving doxorubicin together with bortezomib works in treating patients with liver cancer. Drugs used in chemotherapy, such as doxorubicin, work in different ways to stop tumor cells from dividing so they stop growing or die. Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Giving doxorubicin together with bortezomib may kill more tumor cells.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdult Primary Hepatocellular Carcinoma, Advanced Adult Primary Liver Cancer, Localized Unresectable Adult Primary Liver Cancer, Recurrent Adult Primary Liver Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 17, 2004
Enrollment StartMar 1, 2004
Primary CompletionFeb 1, 2011
Study CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 6.9 yearsPosted 22.1 years ago

Interventions

doxorubicindrug

Given IV

bortezomibdrug

Given IV