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

NCT00293397 | Completed Results

• 4 other identifiers: CDR0000456493P30CA006973JHOC-J0516HOC-05042805
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cancer

Keywords

adult primary hepatocellular carcinoma; localized unresectable adult primary liver cancer

Outcome Measures

Primary Outcomes (7)

• Safety

  Safety was assessed using the CTCAE v 3.0 criteria, reported are the number of participants that experienced at least 1 event that was grade 2 (moderate) or higher.

  1 month

• Safety

  Safety was assessed using the CTCAE v 3.0 criteria, reported are the number of participants that experienced at least 1 event that was grade 2 (moderate) or higher.

  6 months

• Efficacy - Tumor Response by the European Association for the Study of the Liver (EASL) Criteria

  Efficacy as assessed by radiographic tumor response using EASL criteria at baseline and at 1 month post-TACE Complete Response (CR): Achieving 100% tumor necrosis of targeted lesions Partial Response (PR): Demonstrating greater than 50% tumor necrosis in targeted lesions Progressive Disease (PD): Reappearance of or increased tumor enhancement greater than 25% in targeted lesions Stable Disease (SD): Not meeting requirements for CR or PR and not demonstrating evidence of progression in targeted lesions.

  1 month

• Efficacy - Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST)

  Efficacy as assessed by radiographic tumor response using RECIST criteria at baseline, 1 month post treatment. Complete Response (CR): Disappearance of all lesions targeted by therapy Partial Response (PR): At least 30% decrease in the sum of longest diameter (LD) of lesions targeted by therapy Progressive Disease (PD): At least 20% increase in sum of LD of lesions targeted by therapy Stable Disease (SD): Neither sufficient shrinkage for PR nor sufficient increase for PD.

  1 month

• Efficacy - Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST)

  Efficacy as assessed by radiographic tumor response using RECIST criteria at baseline, and at 6 months post treatment. Complete Response (CR): Disappearance of all lesions targeted by therapy Partial Response (PR): At least 30% decrease in the sum of longest diameter (LD) of lesions targeted by therapy Progressive Disease (PD): At least 20% increase in sum of LD of lesions targeted by therapy Stable Disease (SD): Neither sufficient shrinkage for PR nor sufficient increase for PD.

  6 months

• Efficacy - Overall Survival

  Presented are the counts of patients that have survived up to 1 year.

  1 Year

• Efficacy - Overall Survival

  Presented are the counts of patients that have survived up to 2 years.

  2 Years

Study Arms (1)

Drug-eluting bead transarterial chemoembolization (DEB-TACE)

EXPERIMENTAL

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.

Device: Drug-eluting beads loaded with doxorubicin hydrochloride

Interventions

Drug-eluting beads loaded with doxorubicin hydrochloride DEVICE

Doxorubicin eluting beads

Also known as: Gelspheres, LC Beads

Drug-eluting bead transarterial chemoembolization (DEB-TACE)

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Diagnosis of hepatocellular carcinoma (HCC) according to the European Association for the Study of Liver (EASL) disease diagnostic criteria AND the Okuda staging classification * No advanced disease, as defined by any of the following: * Barcelona Clinic Liver Cancer (BCLC) class C disease, as defined by the following: * Vascular invasion, including segmental portal obstruction * Extrahepatic spread * Cancer-related symptoms (PST of 1-2) * BCLC class D disease, as defined by the following: * Okuda stage III disease * World Health Organization (WHO) performance status 3 or 4 * Diffuse HCC, defined as massive ill-defined tumor involvement * Child-Pugh Class C * Not eligible for radical therapies (e.g., resection, liver transplantation, or percutaneous therapies) * 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Yale University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

Related Publications (1)

• 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.

  PMID: 20010173 RESULT

MeSH Terms

Conditions

Liver Neoplasms; Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Results Point of Contact

• Title: Jean-Francois Geschwind, MD
• Organization: Yale University

jeff.geschwind@yale.edu

203-785-5865

Study Officials

• Jeffrey F. Geschwind, MD

  Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2006
• First Posted: February 17, 2006
• Study Start: November 1, 2005
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: July 18, 2018
• Results First Posted: July 18, 2018

Record last verified: 2018-06

Locations

US (1)