Safety and Efficacy of Doxorubicin Adsorbed to Magnetic Beads Vs. IV Doxorubicin in Treating Liver Cancer
NCT ID: NCT00034333
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2/PHASE3
240 participants
INTERVENTIONAL
2002-03-31
Brief Summary
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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
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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MTC-DOX for Injection
Eligibility Criteria
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Inclusion Criteria
* 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.
18 Years
80 Years
ALL
No
Sponsors
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FeRx
INDUSTRY
Principal Investigators
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Joy Koda, Ph.D.
Role: STUDY_CHAIR
FeRx
Locations
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Long Beach VA Medical Center
Long Beach, California, United States
VAMC San Francisco and Comprehensive Cancer Ctr.
San Francisco, California, United States
Northwestern Univ. Med. School
Chicago, Illinois, United States
Weill Medical College of Cornell University
New York, New York, United States
Univ. of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Allegheny-Singer Research Institute
Pittsburgh, Pennsylvania, United States
University of Texas Medical Branch
Galveston, Texas, United States
Scott & White Mem. Hosp. & Clinic
Temple, Texas, United States
McGuire DVAMC
Richmond, Virginia, United States
Landeskrankenhaus Graz University Hospital
Graz, , Austria
University Hospital Vienna
Vienna, , Austria
University Hospital Cologne
Cologne, , Germany
University Hospital Am Main
Frankfurt, , Germany
Queen Mary Hospital, University of Hong Kong
Pokfulam, , Hong Kong
Chinese Universtiy of Hong Kong
Shatin, N.T., , Hong Kong
Central Research Institute of Roentgenology and Radiology
Pesochny, Sankt-Peterburg, Russia
N.N. Blokhin Cancer Research Center RAMS
Moscow, , Russia
Chulalongkorn University Hospital
Bangkok, , Thailand
Siriraj Hospital, Mahidol University
Bangkok, , Thailand
National Cancer Institute
Bangkok, , Thailand
Chiang Mai University
Chiang Mai, , Thailand
Khon Kaen Universtiy
Khon Kaen, , Thailand
Institute of Oncology AMS of Ukraine
Kiev, , Ukraine
Queen Elizabeth Hospital
Edgbaston, Birmingham, United Kingdom
Leicester Royal Infirmary
Leicester, England, United Kingdom
St. George's Hospital
London, England, United Kingdom
Edinburgh Royal Infirmary
Edinburgh, Scotland, United Kingdom
Countries
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Other Identifiers
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MTC-DOX-004
Identifier Type: -
Identifier Source: org_study_id
NCT00052819
Identifier Type: -
Identifier Source: nct_alias