HAI Abraxane With Gemcitabine and Bevacizumab

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT01057264
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Cancers

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • HAI Abraxane — DRUG
    Starting dose: 120 mg/m\^2 by HAI infusion over 24 hours on Day 1 of 21 day cycle
  • Gemcitabine — DRUG
    Starting dose: 600 mg/m\^2 by IV on Days 1 and 8 of 21 day cycle
  • Bevacizumab — DRUG
    10 mg/kg IV on Day 1 of 21 day cycle
  • Filgrastim — DRUG
    5 mcg/kg subcutaneously starting at least 24 hours after Day 1 completion of chemotherapy, for 3 days.

Study Details

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.

Key Dates

First listed
Jan 27, 2010
Start date
Jan 31, 2010
Status verified
Nov 2015
Primary completion
May 31, 2014
Completion
May 31, 2014

Study Design

Enrollment
78 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: HAI Abraxane + Gemcitabine + Bevacizumab
    HAI (hepatic arterial infusions) Abraxane with Gemcitabine + Bevacizumab

Primary Outcome Measure

Maximum Tolerated Dose (MTD) of Escalating Doses of Hepatic Arterial Infusions of Abraxane in Combination with Gemcitabine and Bevacizumab [ Time Frame: 21 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
UT MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By research site
UT MD Anderson Cancer Center· Houston, TX

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