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HAI Abraxane With Gemcitabine and Bevacizumab

NCT01057264 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2015-11-18

No results posted yet for this study

Summary

The goal of this clinical research study is to find the highest tolerable dose of Abraxane® (nab-paclitaxel) when given directly into the liver, in combination with Gemzar® (gemcitabine) and Avastin® (bevacizumab) when given by vein.

Conditions

Interventions

DRUG

HAI Abraxane

Starting dose: 120 mg/m\^2 by HAI infusion over 24 hours on Day 1 of 21 day cycle

DRUG

Gemcitabine

Starting dose: 600 mg/m\^2 by IV on Days 1 and 8 of 21 day cycle

DRUG

Bevacizumab

10 mg/kg IV on Day 1 of 21 day cycle

DRUG

Filgrastim

5 mcg/kg subcutaneously starting at least 24 hours after Day 1 completion of chemotherapy, for 3 days.

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Apostolia M. Tsimberidou, MD, PHD · UT MD Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2014-05-31
Completion
2014-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT01057264 on ClinicalTrials.gov