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Heat Activated Liposomal Doxorubicin and Radiofrequency Ablation in Treating Patients With Primary or Metastatic Liver Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00093444
Recruitment Status : Completed
First Posted : October 8, 2004
Last Update Posted : March 15, 2012
National Cancer Institute (NCI)
Information provided by:
National Institutes of Health Clinical Center (CC)

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as liposomal doxorubicin, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiofrequency ablation uses high-frequency electric current to kill tumor cells. Combining radiofrequency ablation with liposomal doxorubicin may increase the effectiveness of the drug and kill more tumor cells.

PURPOSE: This phase I trial is studying the best dose of liposomal doxorubicin when given with radiofrequency ablation in treating patients with primary or metastatic liver tumors.

Condition or disease Intervention/treatment Phase
Liver Cancer Metastatic Cancer Drug: lyso-thermosensitive liposomal doxorubicin Procedure: radiofrequency ablation Phase 1

Detailed Description:


  • Determine the maximum tolerated dose of heat activated doxorubicin HCl liposome when combined with radiofrequency ablation in patients with primary or metastatic tumors of the liver.
  • Determine the pharmacokinetics and pharmacodynamics of this drug in these patients.

OUTLINE: This is a dose-escalation study of heat activated doxorubicin HCl liposome.

Patients receive doxorubicin HCl liposome IV over 30 minutes. Approximately 15 minutes after the beginning of the doxorubicin HCl liposome infusion, patients undergo radiofrequency ablation with needles inserted into the tumor(s) and heated to the target temperature for approximately 12-60 minutes.

Cohorts of 3-6 patients receive escalating doses of heat activated doxorubicin HCl liposome until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.

Patients are followed at 28 days, every 3 months for 1 year, and then every 6 months for 2 years.

PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study within 2 years.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Primary Purpose: Treatment
Official Title: A Phase I Dose Escalation Study Of Heat Activated Liposome Delivery Of Doxorubicin And Radiofrequency Ablation Of Primary And Metastatic Tumors Of The Liver
Study Start Date : September 2004
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer

Primary Outcome Measures :
  1. Maximum tolerated dose of heat-activated doxorubicin HCL liposome
  2. Pharmacokinetics and pharmacodynamics of heat-activated doxorubicin HCL liposome at 15, 30, 45, 60, 75, and 90 minutes; 2, 3, 4, 6, 24, and 46 hours; and 4 and 8 days following infusion

Secondary Outcome Measures :
  1. Effects of ablative therapy on tumor blood flow and tumor vascular density as measured by MRI at 28 days following study completion

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed tumor of the liver

    • Primary or metastatic disease
    • No more than 4 lesions
    • No single lesion > 7 cm in maximum diameter
  • Not a candidate for curative surgical resection due to tumor histology or prior surgery



  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • At least 3 months


  • Platelet count ≥ 75,000/mm^3
  • WBC ≥ 1,500/mm^3
  • Hemoglobin ≥ 10 g/dL (transfusions to attain levels ≥ 10g/dL allowed)


  • Bilirubin ≤ 2.0 mg/dL
  • PT or PTT ≤ 1.5 times control (except for patients receiving anticoagulation therapy for an unrelated medical condition [e.g., atrial fibrillation])


  • Creatinine ≤ 2.5 mg/dL


  • See Hepatic
  • Ejection fraction ≥ 50% by MUGA
  • No congestive heart failure
  • No myocardial infarction within the past 6 months
  • No cerebral vascular accident within the past 6 months
  • No life-threatening cardiac arrhythmia


  • Weight < 136 kg
  • Glucose ≤ 300 mg/dL
  • No uncontrolled diabetes
  • No known serious uncontrolled reaction (e.g., anaphylaxis) to contrast agents used in this study
  • No known allergy to egg or egg products
  • No other serious medical illness
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception


Biologic therapy

  • No concurrent interferon
  • No live vaccines (for immunosuppressed patients only) during and for 30 days after study treatment


  • Not specified

Endocrine therapy

  • Not specified


  • Not specified


  • See Disease Characteristics


  • More than 3 weeks since prior therapy for liver tumor(s)
  • More than 3 weeks since prior systemic therapy for non-life-threatening extrahepatic disease and recovered
  • No other concurrent systemic therapy
  • No administration of any of the following medications during and for 30 days after study treatment:

    • Cyclosporine
    • Phenobarbital
    • Phenytoin
    • Streptozocin
  • No concurrent administration of any of the following medications:

    • Amphotericin B by injection
    • Antithyroid agents for overactive thyroid
    • Azathioprine
    • Chloramphenicol
    • Colchicine
    • Flucytosine
    • Ganciclovir
    • Plicamycin
    • Zidovudine
    • Probenecid
    • Sulfinpyrazone

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00093444

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United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, United States, 20892-1182
Queen Mary Hospital - Hong Kong
Hong Kong, China
Sponsors and Collaborators
National Institutes of Health Clinical Center (CC)
National Cancer Institute (NCI)
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Study Chair: Bradford Wood, MD National Cancer Institute (NCI)

Layout table for additonal information Identifier: NCT00093444    
Obsolete Identifiers: NCT00090805
Other Study ID Numbers: 040263
First Posted: October 8, 2004    Key Record Dates
Last Update Posted: March 15, 2012
Last Verified: March 2012
Keywords provided by National Institutes of Health Clinical Center (CC):
advanced adult primary liver cancer
liver metastases
localized unresectable adult primary liver cancer
recurrent adult primary liver cancer
Additional relevant MeSH terms:
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Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action