CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 16 enrolled
Drug / intervention
gemcitabine hydrochloride +8 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00645710
NCT00645710Phase 2Completed

A Phase I/II Trial of Radioimmunotherapy (Y-90 cT84.66), Gemcitabine and Hepatic Arterial Infusion of Fudr for Metastatic Colorectal Carcinoma to the Liver

City of Hope Medical Center·interventional·Posted Mar 28, 2008·Updated Mar 28, 2019

In Brief

A Phase 2 clinical trial evaluating gemcitabine hydrochloride, floxuridine, and 7 other interventions for Liver Metastases and 4 related conditions. Completed, enrolled 16 participants across 1 site.

Detailed Summary

RATIONALE: Drugs used in chemotherapy, such as floxuridine and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Hepatic arterial infusion uses a catheter to carry cancer-killing substances directly into the liver. Radiolabeled monoclonal antibodies can find tumor cells and carry tumor-killing substances to them without harming normal cells. Giving hepatic arterial infusion of floxuridine together with gemcitabine hydrochloride and radiolabeled monoclonal antibody therapy after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase I/II trial is studying the side effects and best dose of floxuridine when given as a hepatic arterial infusion together with gemcitabine hydrochloride and radiolabeled monoclonal antibody therapy and to see how well it works in treating liver metastases in patients with metastatic colorectal cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 28, 2008
Enrollment StartFeb 11, 2005
Primary CompletionFeb 7, 2018
TodayJul 2, 2026
Enrollment to primary: 13.0 yearsPosted 18.3 years ago

Interventions

gemcitabine hydrochloridedrug

Given IV

floxuridinedrug

Given via hepatic arterial infusion

proteomic profilinggenetic

Correlative studies

matrix-assisted laser desorption/ionization time of flight mass spectrometryother

Correlative studies

liquid chromatographyother

Correlative studies

yttrium Y 90 anti-CEA monoclonal antibody cT84.66radiation

Given IV

laboratory biomarker analysisother

Correlative studies

mass spectrometryother

Correlative studies

pharmacological studyother

Correlative studies