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

Carcinoma, Hepatocellular Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00034333
• Other study ID #: MTC-DOX-004
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: April 25, 2002
• Last updated: June 23, 2005
• Start date: March 2002

Study information

• Verified date: May 2004
• Source: FeRx
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Other known NCT identifiers

• NCT00052819

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 240
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular

Intervention

Drug:
• MTC-DOX for Injection

Locations

Country	Name	City	State
Austria	Landeskrankenhaus Graz University Hospital	Graz
Austria	University Hospital Vienna	Vienna
Germany	University Hospital Cologne	Cologne
Germany	University Hospital Am Main	Frankfurt
Hong Kong	Queen Mary Hospital, University of Hong Kong	Pokfulam
Hong Kong	Chinese Universtiy of Hong Kong	Shatin, N.T.
Russian Federation	N.N. Blokhin Cancer Research Center RAMS	Moscow
Russian Federation	Central Research Institute of Roentgenology and Radiology	Pesochny	St. Petersburg
Thailand	Chulalongkorn University Hospital	Bangkok
Thailand	National Cancer Institute	Bangkok
Thailand	Siriraj Hospital, Mahidol University	Bangkok
Thailand	Chiang Mai University	Chiang Mai
Thailand	Khon Kaen Universtiy	Khon Kaen
Ukraine	Institute of Oncology AMS of Ukraine	Kiev
United Kingdom	Queen Elizabeth Hospital	Edgbaston	Birmingham
United Kingdom	Edinburgh Royal Infirmary	Edinburgh	Scotland
United Kingdom	Leicester Royal Infirmary	Leicester	England
United Kingdom	St. George's Hospital	London	England
United States	Univ. of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Northwestern Univ. Med. School	Chicago	Illinois
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	University of Texas Medical Branch	Galveston	Texas
United States	Long Beach VA Medical Center	Long Beach	California
United States	Weill Medical College of Cornell University	New York	New York
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Allegheny-Singer Research Institute	Pittsburgh	Pennsylvania
United States	McGuire DVAMC	Richmond	Virginia
United States	VAMC San Francisco and Comprehensive Cancer Ctr.	San Francisco	California
United States	Scott & White Mem. Hosp. & Clinic	Temple	Texas

Sponsors (1)

Lead Sponsor	Collaborator
FeRx

Countries where clinical trial is conducted

United States,  Austria,  Germany,  Hong Kong,  Russian Federation,  Thailand,  Ukraine,  United Kingdom,