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Safety and Efficacy of Doxorubicin Adsorbed to Magnetic Beads Vs. IV Doxorubicin in Treating Liver Cancer

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.
 
ClinicalTrials.gov Identifier: NCT00034333
Recruitment Status : Terminated
First Posted : April 26, 2002
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:
FeRx

Tracking Information
First Submitted Date  ICMJE April 25, 2002
First Posted Date  ICMJE April 26, 2002
Last Update Posted Date June 24, 2005
Study Start Date  ICMJE March 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Doxorubicin Adsorbed to Magnetic Beads Vs. IV Doxorubicin in Treating Liver Cancer
Official Title  ICMJE 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
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

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Carcinoma, Hepatocellular
Intervention  ICMJE Drug: MTC-DOX for Injection
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Enrollment  ICMJE
 (submitted: June¬†23,¬†2005)
240
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Germany,   Hong Kong,   Russian Federation,   Thailand,   Ukraine,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00034333
Other Study ID Numbers  ICMJE MTC-DOX-004
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE FeRx
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Joy Koda, Ph.D. FeRx
PRS Account FeRx
Verification Date May 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP