Clinical trial NCT00293397: Chemoembolization Using Doxorubicin in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery
Official title: Treatment of Patients With Hepatocellular Carcinoma Using Drug-Eluting Bead Embolization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Cancer
Keywords: adult primary hepatocellular carcinoma
localized unresectable adult primary liver cancer
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2006-02-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety
timeFrame: 1 month
measure: Safety
timeFrame: 6 months
measure: Efficacy - Tumor Response by the European Association for the Study of the Liver (EASL) Criteria
timeFrame: 1 month
measure: Efficacy - Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST)
timeFrame: 1 month
measure: Efficacy - Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST)
timeFrame: 6 months
measure: Efficacy - Overall Survival
timeFrame: 1 Year
measure: Efficacy - Overall Survival
timeFrame: 2 Years
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
Study officials:
affiliation: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
name: Jeffrey F. Geschwind, MD
role: STUDY_CHAIR
References:
citation: 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.