CLINICAL TRIAL SUMMARY

MDACC Study No:2009-0410 (clinicaltrials.gov NCT No: NCT00980239)
Title:A multi-arm Phase I trial of hepatic arterial infusion of irinotecan with 1) systemic bevacizumab 2) systemic bevacizumab and oxaliplatin 3) systemic bevacizumab and cetuximab in patients with advanced cancers metastatic to the liver
Principal Investigator:Apostolia M. Tsimberidou
Treatment Agent:Bevacizumab; Cetuximab; Irinotecan; Oxaliplatin
Study Status:Closed
Study Description:The goal of this clinical research study is to learn the highest tolerable dose
of irinotecan that can be given directly into the liver, in combination with
other drugs given by vein.

The other drug combinations given by vein include bevacizumab alone,
bevacizumab plus oxaliplatin, and bevacizumab plus cetuximab.

This will be tested in patients with advanced solid tumors that have spread to
the liver. The safety of these drug combinations will also be studied.

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Disease Group:Advanced Cancers
Phase of Study:Phase I
Treatment Agents:Bevacizumab
Cetuximab
Irinotecan
Oxaliplatin
Treatment Location:Only at MDACC
Estimated Length of Stay in Houston:4-5 days every 28 days
Supported By:N/A
Return Visit:Weekly during the 1st cycle & thereafter every 4 weeks or earlier as necessary
for a doctor/midlevel visit. The initial or loading doses of bevacizumab,
oxaliplatin, and/or cetuximab will be given in the clinic. Subsequent doses may
be given at home.
Home Care:The initial or loading doses of bevacizumab, oxaliplatin, and/or cetuximab will
be given in the clinic. Subsequent doses may be given at home.


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Physician Name:Apostolia M. Tsimberidou
Dept:Investigational Cancer Therapeutics
For Clinical Trial Enrollment:713-792-4259
For General Questions about Clinical Trials:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)


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