Safety and Efficacy of Doxorubicin Adsorbed to Magnetic Beads Vs. IV Doxorubicin in Treating Liver Cancer
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
1 other identifier
interventional
240
8 countries
29
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2002
CompletedFirst Submitted
Initial submission to the registry
April 25, 2002
CompletedFirst Posted
Study publicly available on registry
April 26, 2002
CompletedJune 24, 2005
May 1, 2004
April 25, 2002
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- 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
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- FeRxlead
Study Sites (29)
Long Beach VA Medical Center
Long Beach, California, 90822, United States
VAMC San Francisco and Comprehensive Cancer Ctr.
San Francisco, California, 94121, United States
Northwestern Univ. Med. School
Chicago, Illinois, 60611, United States
Weill Medical College of Cornell University
New York, New York, 10021, United States
Univ. of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Allegheny-Singer Research Institute
Pittsburgh, Pennsylvania, 15212, United States
University of Texas Medical Branch
Galveston, Texas, 77555, United States
Scott & White Mem. Hosp. & Clinic
Temple, Texas, 76508, United States
McGuire DVAMC
Richmond, Virginia, 23249, United States
Landeskrankenhaus Graz University Hospital
Graz, Austria
University Hospital Vienna
Vienna, Austria
University Hospital Cologne
Cologne, 50924, 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, 197758, Russia
N.N. Blokhin Cancer Research Center RAMS
Moscow, 115478, Russia
Chulalongkorn University Hospital
Bangkok, 10330, Thailand
Siriraj Hospital, Mahidol University
Bangkok, 10700, Thailand
National Cancer Institute
Bangkok, Thailand
Chiang Mai University
Chiang Mai, Thailand
Khon Kaen Universtiy
Khon Kaen, 40002, Thailand
Institute of Oncology AMS of Ukraine
Kiev, 03022, Ukraine
Queen Elizabeth Hospital
Edgbaston, Birmingham, B152TH, United Kingdom
Leicester Royal Infirmary
Leicester, England, United Kingdom
St. George's Hospital
London, England, United Kingdom
Edinburgh Royal Infirmary
Edinburgh, Scotland, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Joy Koda, Ph.D.
FeRx
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 25, 2002
First Posted
April 26, 2002
Study Start
March 1, 2002
Last Updated
June 24, 2005
Record last verified: 2004-05