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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00040898
First received: July 8, 2002
Last updated: January 17, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Liver Cancer
Dietary Supplement: Sho-saiko-to
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Sho-Saiko-To After Ablation for Non-Resectable Hepatocellular Carcinoma (HCC): A Phase II Trial With Historical Control

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Study Start Date: January 2001
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00040898

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Study Chair: Ronald DeMatteo, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00040898     History of Changes
Other Study ID Numbers: 01-002, P30CA008748, MSKCC-01002, NCI-G02-2084
Study First Received: July 8, 2002
Last Updated: January 17, 2013
Health Authority: United States: Federal Government

Keywords provided by Memorial Sloan-Kettering Cancer Center:
localized unresectable adult primary liver cancer
advanced adult primary liver cancer
recurrent adult primary liver cancer
adult primary hepatocellular carcinoma

Additional relevant MeSH terms:
Liver Neoplasms
Carcinoma, Hepatocellular
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on August 19, 2014