Sho-Saiko-To Following Removal of Liver Cancer By Embolization in Treating Patients With Liver Cancer That Cannot Be Surgically Removed

January 17, 2013 updated by: Memorial Sloan Kettering Cancer Center

Sho-Saiko-To After Ablation for Non-Resectable Hepatocellular Carcinoma (HCC): A Phase II Trial With Historical Control

RATIONALE: The Chinese herbal medicine Sho-saiko-to contains ingredients that may slow the growth of tumor cells and stimulate a person's immune system to help kill tumor cells. This may be an effective treatment following hepatic artery embolization.

PURPOSE: Phase II trial to study the effectiveness of Sho-saiko-to following hepatic artery embolization in treating patients who have liver cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Compare the overall survival of patients with unresectable hepatocellular carcinoma treated with Sho-saiko-to after ablation therapy with embolization vs historical control patients.
  • Compare the liver function and alpha fetoprotein levels in patients treated with this drug vs historical control patients.
  • Compare the intervention-free survival in patients treated with this drug vs historical control patients.

OUTLINE: Beginning within 1 week after the first course of ablation therapy with embolization, patients receive oral Sho-saiko-to three times daily. Treatment with Sho-saiko-to continues in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 78 patients will be accrued for this study within 18-24 months.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Memorial Sloan-Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • One of the following conditions:

    • Histologically confirmed unresectable hepatocellular carcinoma
    • Serum alpha-fetoprotein (AFP) level greater than 500 ng/mL with cirrhosis
    • Serum AFP level greater than 500 ng/mL with a liver mass and positive hepatitis B or C serology
  • Receiving ablation therapy with embolization
  • Extrahepatic disease allowed
  • No brain metastases

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count greater than 1,500/mm^3
  • Platelet count greater than 50,000/mm^3
  • Hemoglobin greater than 8.0 g/dL

Hepatic:

  • See Disease Characteristics
  • Bilirubin less than 2.0 mg/dL
  • SGOT or SGPT less than 5 times upper limit of normal (ULN)
  • PT or INR less than 1.6 times ULN (if not receiving warfarin for anticoagulation)
  • Albumin greater than 2.5 g/dL

Renal:

  • Creatinine less than 1.8 mg/dL

Pulmonary:

  • DLCO at least 50% predicted OR
  • DLCO at least 70% predicted if total lung capacity less than 80% predicted
  • No significant lung disease

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
  • No uncontrolled infection or pain
  • No other condition that would significantly impair cognitive functioning during the study
  • No overt psychosis, mental disability, or other incompetency that would preclude study
  • No other life-threatening illness for which the prognosis is poorer than for hepatocellular carcinoma

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No concurrent interferon

Chemotherapy:

  • No prior chemotherapy within 4 weeks of initiating ablation therapy
  • No concurrent chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior radiotherapy within 4 weeks of initiating ablation therapy
  • Concurrent radiotherapy allowed

Surgery:

  • See Disease Characteristics

Other:

  • See Disease Characteristics
  • No prior ablation therapy
  • No other concurrent Sho-saiko-to or any of its constituent plants
  • No other concurrent anticancer medications

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Ronald DeMatteo, MD, Memorial Sloan Kettering Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2001

Primary Completion (Actual)

January 1, 2006

Study Registration Dates

First Submitted

July 8, 2002

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

January 18, 2013

Last Update Submitted That Met QC Criteria

January 17, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01-002
  • P30CA008748 (U.S. NIH Grant/Contract)
  • MSKCC-01002
  • NCI-G02-2084

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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