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Safety and Efficacy of Doxorubicin Adsorbed to Magnetic Beads Vs. IV Doxorubicin in Treating Liver Cancer
This study has been terminated.
First Received: April 25, 2002   Last Updated: June 23, 2005   History of Changes
Sponsor: FeRx
Information provided by: FeRx
ClinicalTrials.gov Identifier: NCT00034333
  Purpose

MTC-DOX is Doxorubicin or DOX, a chemotherapy drug, that is adsorbed, or made to "stick", to magnetic beads (MTCs). MTCs are tiny, microscopic particles of iron and carbon. When DOX is added to MTCs, DOX attaches to the carbon part of the MTCs. MTC-DOX is directed to and deposited in the area of a tumor, where it is thought that it then "leaks" through the blood vessel walls. Once in the surrounding tissues, it is thought that Doxorubicin becomes "free from" the magnetic beads and will then be able to act against the tumor cells. The iron component of the particle has magnetic properties, making it possible to direct MTC-DOX to specific tumor sites in the liver by placing a magnet on the body surface. It is hoped that MTC-DOX used with the magnet may target the chemotherapy directly to liver tumors and provide a treatment to patients with liver cancer.

To be sure of the effect of MTC-DOX on liver cancer, it will be compared to the effect of Doxorubicin given through the vein.

The study treatments will be administered every three weeks, (which is considered a study treatment cycle), until you complete six treatment cycles, the tumor grows, disappears, or you experience a side effect, which may cause you to leave the study. Follow-up visits will occur on Days 3, 10, and 21 following treatment in the first cycle and Days 7 and 21 for the remaining cycles, and also 60 days after you receive your last treatment cycle.

Therefore, the purpose of this Phase 2/3 study is to evaluate safety, tolerance, and efficacy (survival time) of an MTC-DOX dosing strategy where the DOX dose is determined by tumor size


Condition Intervention Phase
Carcinoma, Hepatocellular
Drug: MTC-DOX for Injection
Phase II
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title: Study of Doxorubicin Hydrochloride Adsorbed to Magnetic Targeted Carriers (MTC-DOX) Administered by Intrahepatic Delivery Versus Intravenous Doxorubicin for Treatment of Patients With Unresectable Hepatocellular Carcinoma

Resource links provided by NLM:


Further study details as provided by FeRx:

Estimated Enrollment: 240
Study Start Date: March 2002
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Patients may be enrolled into this protocol only if all of the following inclusion criteria are met:

  • Unresectable hepatocellular carcinoma diagnosed by CT scan and meets the criteria described in Section 23.
  • Total combined cross-sectional area of all hepatic tumors as determined by CT scan is between 4 and 200 cm2.
  • Center of the tumor(s) mass must be </= 14 cm from the anterior lateral abdominal wall as determined by cross-sectional imaging at baseline. This is required for optimal placement of the magnet. If more than one tumor mass is present, all of the tumor masses must meet this criterion.
  • Is ambulatory with a Karnofsky performance status score > 60 and an estimated life expectancy of > 3 months.
  • Is judged by the investigator to have the initiative and means to be compliant with the protocol and be within geographical proximity to allow follow-up.
  • Have the ability to give informed written consent prior to initiation of therapy.
  • If female and of childbearing potential,must have a negative beta-HCG prior to receiving treatment.
  • Must agree to use an effective method of contraception

Patients will be excluded from enrollment if any of the following apply:

  • Has a history of cancer other than hepatocellular (excluding resected basal cell carcinoma; or curatively resected stage 1 or less cervical cancer if disease free for 5 years or more).
  • Has had prior local radiation therapy within the last 4 weeks, mediastinal radiation therapy within the last 3 months, or chemotherapy within the last 4 weeks.
  • Diffuse hepatocellular carcinoma or disease that precludes delivery of the drug to the tumor via a vessel that feeds the tumor.
  • Has another active medical condition(s) or organ disease(s) that may either compromise patient safety or interfere with the safety and/or outcome (e.g., survival) evaluation of the study drugs. While this exclusion is not limited to the following abnormalities, if any of the following laboratory abnormalities are present, the patient should be excluded:

WBC < 2,000 /uL Platelets < 50,000/uL Hemoglobin < 8.0 gm/dL Total bilirubin > 3.0 mg/dL ALT or AST >/= 5 x upper limit of normal Serum Creatinine >2.0 mg/dL INR >/= 1.5

  • Has cardiac dysfunction with a left ventricular ejection fraction < 40%.
  • Has clinically significant pulmonary impairment
  • Plans concomitant chemotherapy, radiation therapy, hormonal and/or biological treatment for cancer including immunotherapy while on study.
  • Has an indwelling cardiac pacemaker, cerebral aneurysm clips, or any other indwelling device or appliance that could be adversely affected by the use of the external magnet.
  • Has documented evidence of hemachromatosis or hemosiderosis.
  • Has CT or ultrasound evidence of portal vein invasion or thrombosis.
  • Prior orthotopic hepatic transplant.
  • Has received previous treatment with doxorubicin, idarubicin, and/or other anthracyclines or anthracenes.
  • Has a known allergy to doxorubicin, MTC-DOX or any of their components.
  • Has been treated with any investigational drug, investigational biologic, or investigational therapeutic device within 30 days of initiating study treatment.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00034333

  Hide Study Locations
Locations
United States, California
Long Beach VA Medical Center
Long Beach, California, United States, 90822
VAMC San Francisco and Comprehensive Cancer Ctr.
San Francisco, California, United States, 94121
United States, Illinois
Northwestern Univ. Med. School
Chicago, Illinois, United States, 60611
United States, New York
Weill Medical College of Cornell University
New York, New York, United States, 10021
United States, North Carolina
Univ. of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Allegheny-Singer Research Institute
Pittsburgh, Pennsylvania, United States, 15212
United States, Texas
Scott & White Mem. Hosp. & Clinic
Temple, Texas, United States, 76508
University of Texas Medical Branch
Galveston, Texas, United States, 77555
United States, Virginia
McGuire DVAMC
Richmond, Virginia, United States, 23249
Austria
University Hospital Vienna
Vienna, Austria
Landeskrankenhaus Graz University Hospital
Graz, Austria
Germany
University Hospital Am Main
Frankfurt, Germany
University Hospital Cologne
Cologne, Germany, 50924
Hong Kong
Queen Mary Hospital, University of Hong Kong
Pokfulam, Hong Kong
Chinese Universtiy of Hong Kong
Shatin, N.T., Hong Kong
Russian Federation
N.N. Blokhin Cancer Research Center RAMS
Moscow, Russian Federation, 115478
Russian Federation, St. Petersburg
Central Research Institute of Roentgenology and Radiology
Pesochny, St. Petersburg, Russian Federation, 197758
Thailand
Chulalongkorn University Hospital
Bangkok, Thailand, 10330
Siriraj Hospital, Mahidol University
Bangkok, Thailand, 10700
Chiang Mai University
Chiang Mai, Thailand
National Cancer Institute
Bangkok, Thailand
Khon Kaen Universtiy
Khon Kaen, Thailand, 40002
Ukraine
Institute of Oncology AMS of Ukraine
Kiev, Ukraine, 03022
United Kingdom, Birmingham
Queen Elizabeth Hospital
Edgbaston, Birmingham, United Kingdom, B152TH
United Kingdom, England
St. George's Hospital
London, England, United Kingdom
Leicester Royal Infirmary
Leicester, England, United Kingdom
United Kingdom, Scotland
Edinburgh Royal Infirmary
Edinburgh, Scotland, United Kingdom
Sponsors and Collaborators
FeRx
Investigators
Study Chair: Joy Koda, Ph.D. FeRx
  More Information

No publications provided

Study ID Numbers: MTC-DOX-004
Study First Received: April 25, 2002
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00034333     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by FeRx:
Hepatoma
Unresectable adult primary liver cancer
liver cancer
HCC
Hepatocellular Carcinoma

Additional relevant MeSH terms:
Liver Diseases
Neoplasms by Histologic Type
Digestive System Neoplasms
Antineoplastic Agents
Carcinoma, Hepatocellular
Antibiotics, Antineoplastic
Pharmacologic Actions
Doxorubicin
Carcinoma
Liver Neoplasms
Neoplasms
Neoplasms by Site
Digestive System Diseases
Therapeutic Uses
Adenocarcinoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 27, 2009