Chemoembolization Using Doxorubicin in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery

NCT ID: NCT00293397

Last Updated: 2018-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-11-30
• Study Completion Date: 2011-04-30

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or stopping them from dividing. Chemoembolization kills tumor cells by blocking the blood flow to the tumor and keeping chemotherapy drugs near the tumor.

PURPOSE: This clinical trial is studying how well chemoembolization using doxorubicin works in treating patients with liver cancer that cannot be removed by surgery.

Detailed Description

OBJECTIVES:

• Determine, preliminarily, the feasibility of chemoembolization with GelSpheres™ beads mixed with doxorubicin hydrochloride in patients with unresectable hepatocellular carcinoma.

OUTLINE: This is a pilot study.

Patients undergo catheterization of the hepatic artery followed by chemoembolization comprising an infusion of GelSpheres™ beads mixed with doxorubicin hydrochloride into the target hepatic artery. Patients may receive up to 3 chemoembolization treatments.

After completion of study treatment, patients are followed at 1 month, every 2 months for 1 year, and then every 3 months during year 2.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Conditions

Liver Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Drug-eluting bead transarterial chemoembolization (DEB-TACE)

Patients undergo DEB-TACE procedures utilizing LC Beads, polyvinyl alcohol microspheres with diameters of 100-300um or 300-500um, which are loaded with 100mg of doxorubicin hydrochloride and mixed with an equal volume of nonionic contrast media.

Group Type: EXPERIMENTAL

Drug-eluting beads loaded with doxorubicin hydrochloride

Intervention Type: DEVICE

Doxorubicin eluting beads

Interventions

Drug-eluting beads loaded with doxorubicin hydrochloride

Doxorubicin eluting beads

Intervention Type: DEVICE

Other Intervention Names

Gelspheres; LC Beads

Eligibility Criteria

Inclusion Criteria

• No significant liver decompensation

• Preserved liver function (Child-Pugh class A-B)

• No ascites (trace ascites allowed)
• No other active primary tumor
• Arteries supplying the lesion must be large enough to accept GelSpheres™ beads

PATIENT CHARACTERISTICS:

• Bilirubin ≤ 3 mg/dL
• Albumin > 2.0 g/dL
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5 times the upper limit of normal (ULN)
• Alkaline phosphatase ≤ 5 times the upper limit of normal (ULN)
• No active gastrointestinal bleeding
• No encephalopathy
• No contraindication to hepatic embolization procedures, as indicated by any of the following:

• Porto-systemic shunt
• Hepatofugal blood flow
• Platelet count < 50,000/mm^3
• International normalized ratio (INR) ≥ 1.8
• Partial thromboplastin time (PTT) ≥ 39 seconds
• Renal failure
• Severe atheromatosis
• No contraindication to doxorubicin hydrochloride administration, as indicated by any of the following:

• Bilirubin > 5 mg/dL
• White blood cell (WBC) < 1,500/mm^3
• Ejection fraction < 50% by isotopic ventriculography or echocardiography
• Not pregnant
• No known allergy to contrast media
• No intolerance to occlusion procedures
• No vascular anatomy or bleeding that would preclude catheter placement or emboli injection, as indicated by any of the following:

• Active or risk of hemorrhage
• Patent extra-to-intracranial anastomoses or shunts
• End arteries leading directly to the cranial nerves
• Feeding arteries smaller than distal branches from which they emerge
• Collateral vessel pathways that would potentially endanger normal territories during embolization

PRIOR CONCURRENT THERAPY:

• No prior anticancer therapy for HCC

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeffrey F. Geschwind, MD

Role: STUDY_CHAIR

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Locations

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Countries

United States

References

Reyes DK, Vossen JA, Kamel IR, Azad NS, Wahlin TA, Torbenson MS, Choti MA, Geschwind JF. Single-center phase II trial of transarterial chemoembolization with drug-eluting beads for patients with unresectable hepatocellular carcinoma: initial experience in the United States. Cancer J. 2009 Nov-Dec;15(6):526-32. doi: 10.1097/PPO.0b013e3181c5214b.

Reference Type: RESULT

PMID: 20010173 (View on PubMed)

Other Identifiers

P30CA006973

Identifier Type: NIH

Identifier Source: secondary_id

View Link

JHOC-J0516

Identifier Type: -

Identifier Source: secondary_id

HOC-05042805

Identifier Type: -

Identifier Source: secondary_id

CDR0000456493

Identifier Type: -

Identifier Source: org_study_id