Hepatic Arterial Infusion (HAI) of Abraxane - Full Text View

Sponsored by:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00732836

Purpose

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.

Primary Objectives

To determine the maximum tolerated doses of hepatic arterial infusion (HAI) of Abraxane in advanced solid cancer patients with predominant hepatic metastases.
To compare pharmacokinetic analyses of HAI Abraxane and intravenous Abraxane, especially the time to peak that might be a more sensitive indicator of the effect of first-pass hepatic extraction on drug bioavailability.

Secondary Objectives

To assess by RECIST clinical responses signals in a broad array of solid tumors.
To evaluate whether dynamic contrast enhanced MRI to determine the degree of vascular permeability and PET scan to delineate tumor viability and glucose uptake are able to predict major clinical outcomes.
To assess whether biomarkers such as gp60, SPARC, caveolin-1, and p-glycoprotein can predict major clinical outcomes.

Condition	Intervention	Phase
Liver Cancer Advanced Cancers Solid Tumors	Drug: Abraxane Procedure: Hepatic Artery Catheter	Phase I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study
Official Title:	Phase I Trial of Hepatic Arterial Infusion of Abraxane With a Pharmacokinetic Study in Advanced Solid Cancer Patients With Predominant Hepatic Metastases

Resource links provided by NLM:

MedlinePlus related topics: Cancer Liver Cancer

Drug Information available for: Paclitaxel

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

Highest tolerated dose of Abraxane (nab-paclitaxel) [ Time Frame: Assessments every 3 weeks (each cycle) ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	42
Study Start Date:	June 2008
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Cycle 1: Experimental Intravenous Abraxane First 21 Day Cycle only, 60 minute infusion of Abraxane by a vein in arm.	Drug: Abraxane First Cycle (Intravenous Abraxane): 180 mg/m^2 every 21 days Second Cycle (HAI Abraxane): 180 mg/m^2 every 21 days Third Cycle(HAI Abraxane): 220 mg/m^2 every 21 days Fourth Cycle(HAI Abraxane): 260 mg/m^2 every 21 days
Cycle 2: Experimental Hepatic Arterial Infusion of Abraxane (HAI Abraxane) Second 21 Day Cycle, 60 minute infusion of abraxane through a catheter advanced to the liver (HAI abraxane) via a blood vessel in right groin.	Drug: Abraxane First Cycle (Intravenous Abraxane): 180 mg/m^2 every 21 days Second Cycle (HAI Abraxane): 180 mg/m^2 every 21 days Third Cycle(HAI Abraxane): 220 mg/m^2 every 21 days Fourth Cycle(HAI Abraxane): 260 mg/m^2 every 21 days Procedure: Hepatic Artery Catheter On each day of treatment for Second through Fourth Cycles, interventional radiology will complete hepatic artery catheter placement.
Cycle 3: Experimental Hepatic Arterial Infusion of Abraxane (HAI abraxane) Third 21 Day Cycle, 60 minute infusion of escalated abraxane through a catheter advanced to the liver via a blood vessel in right groin.	Drug: Abraxane First Cycle (Intravenous Abraxane): 180 mg/m^2 every 21 days Second Cycle (HAI Abraxane): 180 mg/m^2 every 21 days Third Cycle(HAI Abraxane): 220 mg/m^2 every 21 days Fourth Cycle(HAI Abraxane): 260 mg/m^2 every 21 days Procedure: Hepatic Artery Catheter On each day of treatment for Second through Fourth Cycles, interventional radiology will complete hepatic artery catheter placement.
Cycle 4: Experimental Hepatic Arterial Infusion of Abraxane (HAI Abraxane) Fourth 21 Day Cycle, 60 minute infusion of second escalation of abraxane through a catheter advanced to the liver via a blood vessel in right groin.	Drug: Abraxane First Cycle (Intravenous Abraxane): 180 mg/m^2 every 21 days Second Cycle (HAI Abraxane): 180 mg/m^2 every 21 days Third Cycle(HAI Abraxane): 220 mg/m^2 every 21 days Fourth Cycle(HAI Abraxane): 260 mg/m^2 every 21 days Procedure: Hepatic Artery Catheter On each day of treatment for Second through Fourth Cycles, interventional radiology will complete hepatic artery catheter placement.

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Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Pathologically confirmed diagnosis of advanced malignancy and liver involvement as predominant site of metastasis.
An ECOG performance status of 0-2
Adequate end-organ function as follows: ANC > or = 1500/mm3, Platelets > or = 100,000/mm3, Creatinine < or = 2.0 mg/dL or the calculated GFR > or = 40 mL/min if Creatinine > 2.0 mg/dL, ALT < or = 5 times upper limits of normal, Hb > 9.0 and Bilirubin < or = 2.0 mg/dL.
Refractory to standard cancer therapy or who have no conventional therapy that produces a complete response rate of at least 10% or an increase in survival of at least 3 months.
Ability to fully comprehend and willingness to sign the IRB-approved informed consent
Full recovery from any previous therapy and ability to receive cytotoxic agents.
Patient is 18 years of age or older

Exclusion Criteria:

Clinically significant ascites.
Pregnant or breastfeeding females. Women of childbearing potential should be advised to avoid becoming pregnant and men to not father a child while receiving treatment. Women of childbearing potential must have a negative pregnancy test.
Hypersensitivity to Abraxane
Untreatable bleeding diathesis
Evidence of portal vein thrombosis and clinically significant peripheral vascular disease
Neuropathy of grade 2 or higher
A known history of CNS metastasis unless the patients are neurologically stable after treatment with surgery and/or radiation therapy
If the patient progressed on abraxane previously they will not be eligible for the dose escalation portion or the PK studies only. These patients can be included in the dose expansion portion of the trial.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00732836

Contacts

Contact: Razelle Kurzrock, MD, BS	713-794-1226
Contact: Michelle K Calabretta, PhD	713-563-0896

Locations

United States, Texas
U.T. M.D. Anderson	Recruiting
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Razelle Kurzrock, MD, BS

U.T. M.D. Anderson Cancer Center

More Information

Additional Information:

U.T. M.D. Anderson Cancer Center Website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	U.T. M.D. Anderson Cancer Center ( Razelle Kurzrock, MD, BS, Professor )
Study ID Numbers:	2007-0857
Study First Received:	August 8, 2008
Last Updated:	August 4, 2009
ClinicalTrials.gov Identifier:	NCT00732836 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Liver Cancer
Solid Cancer
Abraxane
nab paclitaxel

HAI abraxane
HAI
hepatic arterial infusion
hepatic metastases

Study placed in the following topic categories:

Liver Neoplasms
Liver Diseases
Digestive System Diseases
Digestive System Neoplasms
Paclitaxel

Tubulin Modulators
Neoplasm Metastasis
Gastrointestinal Neoplasms
Antimitotic Agents
Antineoplastic Agents, Phytogenic

Additional relevant MeSH terms:

Liver Diseases
Digestive System Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Antimitotic Agents
Pharmacologic Actions
Liver Neoplasms

Neoplasms
Neoplasms by Site
Digestive System Diseases
Paclitaxel
Therapeutic Uses
Tubulin Modulators
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on August 25, 2009