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

NCT ID: NCT00040898

Last Updated: 2013-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-01-31

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.

Conditions

Liver Cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

Sho-saiko-to

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Principal Investigators

Ronald DeMatteo, MD

Role: STUDY_CHAIR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Countries

United States

Other Identifiers

P30CA008748

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MSKCC-01002

Identifier Type: -

Identifier Source: secondary_id

NCI-G02-2084

Identifier Type: -

Identifier Source: secondary_id

01-002

Identifier Type: -

Identifier Source: org_study_id