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Hepatic Arterial Infusion (HAI) of Abraxane

NCT00732836 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2016-02-05

No results posted yet for this study

Summary

The goal of this clinical research study is find the highest tolerated dose of Abraxane (nab-paclitaxel) that can be given directly into the liver of patients with advanced cancer that has spread to the liver.

Conditions

Interventions

DRUG

HAI Abraxane

Escalating doses (beginning dose 180 mg/m\^2) starting Day 1, Cycle 2 and later via hepatic arterial infusion (HAI) following IV Abraxane in Day 1, Cycle 1 for 21 day cycles.

PROCEDURE

Hepatic Artery Catheter

On each day of treatment for Cycles 2-4, hepatic artery catheter placement completed by interventional radiology.

DRUG

IV Abraxane

Intravenous (IV) Abraxane only in Cycle 1 (up to Dose Level 4 of 260 mg/m\^2), infused over 60 minutes or 4 hours Day 1 of 21 day cycle.

Sponsors & Collaborators

Principal Investigators

  • Siqing Fu, MD, PHD · M.D. Anderson Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2016-01-31
Completion
2016-01-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00732836 on ClinicalTrials.gov