Know Cancer

or
forgot password

Sho-Saiko-To After Ablation for Non-Resectable Hepatocellular Carcinoma (HCC): A Phase II Trial With Historical Control


Phase 2
18 Years
N/A
Not Enrolling
Both
Liver Cancer

Thank you

Trial Information

Sho-Saiko-To After Ablation for Non-Resectable Hepatocellular Carcinoma (HCC): A Phase II Trial With Historical Control


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.

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Ronald DeMatteo, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

01-002

NCT ID:

NCT00040898

Start Date:

January 2001

Completion Date:

Related Keywords:

  • Liver Cancer
  • localized unresectable adult primary liver cancer
  • advanced adult primary liver cancer
  • recurrent adult primary liver cancer
  • adult primary hepatocellular carcinoma
  • Liver Neoplasms
  • Carcinoma, Hepatocellular

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021