Hepatic Arterial Infusion (HAI) of Abraxane

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00732836
First received: August 8, 2008
Last updated: October 24, 2013
Last verified: October 2013
  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:


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 2015 (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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Pathologically confirmed diagnosis of advanced malignancy and liver involvement as predominant site of metastasis.
  2. An ECOG performance status of 0-2
  3. 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.
  4. 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.
  5. Ability to fully comprehend and willingness to sign the IRB-approved informed consent
  6. Full recovery from any previous therapy and ability to receive cytotoxic agents.
  7. Patient is 18 years of age or older

Exclusion Criteria:

  1. Clinically significant ascites.
  2. 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.
  3. Hypersensitivity to Abraxane
  4. Untreatable bleeding diathesis
  5. Evidence of portal vein thrombosis and clinically significant peripheral vascular disease
  6. Neuropathy of grade 2 or higher
  7. A known history of CNS metastasis unless the patients are neurologically stable after treatment with surgery and/or radiation therapy
  8. 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Siqing Fu, MD, PHD M.D. Anderson Cancer Center
  More Information

Additional Information:
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: October 24, 2013
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
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 16, 2014