Expired Study
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New York, New York 10021


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.


Study summary:

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.


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


NCT ID:

NCT00040898


Primary Contact:

Study Chair
Ronald DeMatteo, MD
Memorial Sloan-Kettering Cancer Center


Backup Contact:

N/A


Location Contact:

New York, New York 10021
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 15, 2017

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