Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00034333
Status:
TERMINATED
Last Update Posted:
2005-06-24
First Post:
2002-04-25
Brief Title:
Safety and Efficacy of Doxorubicin Adsorbed to Magnetic Beads Vs IV Doxorubicin in Treating Liver Cancer
Sponsor:
FeRx
Organization:
FeRx
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2004-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 23 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
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 23 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None