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

Sponsor:	M.D. Anderson Cancer Center
Information provided by (Responsible Party):	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.

Condition	Intervention	Phase
Liver Cancer Advanced Cancers Solid Tumors	Drug: HAI Abraxane Procedure: Hepatic Artery Catheter Drug: IV Abraxane	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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:

Maximum Tolerated Dose (MTD) of HAI Abraxane [ Time Frame: Assessments every 3 week cycle (21 days) ] [ Designated as safety issue: Yes ]
MTD is highest dose level in which 6 patients with at most 1 patient experiencing a dose limiting toxicity (DLT). Dose escalation continues until DLT is defined or until dose level 4 is completed. DLT defined during first cycle of treatment.

Estimated Enrollment:	56
Study Start Date:	June 2008
Estimated Primary Completion Date:	June 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: HAI Abraxane MTD Dose escalation beginning Day 1, Cycle 2 dose level 180 mg/m^2 for maximum tolerated dose (MTD) of Hepatic Arterial Infusion of Abraxane (HAI Abraxane) following same dose intravenous Abraxane in Cycle 1 of 21 day cycle.	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. Other Names: Nab Abraxane Paclitaxel (protein-bound) Nab-paclitaxel Abraxane Coroxane Capxol Procedure: Hepatic Artery Catheter On each day of treatment for Cycles 2-4, hepatic artery catheter placement completed by interventional radiology. Other Names: Hepatic artery catheter HAI 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. Other Names: Nab Abraxane Paclitaxel (protein-bound) Nab-paclitaxel Abraxane Coroxane Capxol
Experimental: HAI Abraxane Expansion HAI Abraxane dose expansion at MTD or dose level 3 (260 mg/m^2) if MTD not defined.	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. Other Names: Nab Abraxane Paclitaxel (protein-bound) Nab-paclitaxel Abraxane Coroxane Capxol Procedure: Hepatic Artery Catheter On each day of treatment for Cycles 2-4, hepatic artery catheter placement completed by interventional radiology. Other Names: Hepatic artery catheter HAI

Arms

Assigned Interventions

Experimental: HAI Abraxane MTD

Dose escalation beginning Day 1, Cycle 2 dose level 180 mg/m^2 for maximum tolerated dose (MTD) of Hepatic Arterial Infusion of Abraxane (HAI Abraxane) following same dose intravenous Abraxane in Cycle 1 of 21 day cycle.

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.

Other Names:

Nab Abraxane
Paclitaxel (protein-bound)
Nab-paclitaxel
Abraxane
Coroxane
Capxol

Procedure: Hepatic Artery Catheter

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

Other Names:

Hepatic artery catheter
HAI

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.

Other Names:

Nab Abraxane
Paclitaxel (protein-bound)
Nab-paclitaxel
Abraxane
Coroxane
Capxol

Experimental: HAI Abraxane Expansion

HAI Abraxane dose expansion at MTD or dose level 3 (260 mg/m^2) if MTD not defined.

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.

Other Names:

Nab Abraxane
Paclitaxel (protein-bound)
Nab-paclitaxel
Abraxane
Coroxane
Capxol

Procedure: Hepatic Artery Catheter

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

Other Names:

Hepatic artery catheter
HAI

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Eligibility

Ages Eligible for Study:	18 Years and older
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

Locations

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

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

David S. Hong, MD

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:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00732836 History of Changes
Other Study ID Numbers:	2007-0857
Study First Received:	August 8, 2008
Last Updated:	May 17, 2012
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

Additional relevant MeSH terms:

Liver Neoplasms
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Paclitaxel
Tubulin Modulators

Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2012