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

July 8, 2002
January 17, 2013
January 2001
January 2006   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00040898 on ClinicalTrials.gov Archive Site
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Sho-Saiko-To Following Removal of Liver Cancer By Embolization in Treating Patients With Liver Cancer That Cannot Be Surgically Removed
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.

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.

Interventional
Phase 2
Primary Purpose: Treatment
Liver Cancer
Dietary Supplement: Sho-saiko-to
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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January 2006   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00040898
01-002, P30CA008748, MSKCC-01002, NCI-G02-2084
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Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: Ronald DeMatteo, MD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP