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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

Primary Purpose

Liver Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Sho-saiko-to
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cancer focused on measuring localized unresectable adult primary liver cancer, advanced adult primary liver cancer, recurrent adult primary liver cancer, adult primary hepatocellular carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Memorial Sloan-Kettering Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 8, 2002
Last Updated
January 17, 2013
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00040898
Brief Title
Sho-Saiko-To Following Removal of Liver Cancer By Embolization in Treating Patients With Liver Cancer That Cannot Be Surgically Removed
Official Title
Sho-Saiko-To After Ablation for Non-Resectable Hepatocellular Carcinoma (HCC): A Phase II Trial With Historical Control
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
January 2001 (undefined)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer
Keywords
localized unresectable adult primary liver cancer, advanced adult primary liver cancer, recurrent adult primary liver cancer, adult primary hepatocellular carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Dietary Supplement
Intervention Name(s)
Sho-saiko-to

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald DeMatteo, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

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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

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