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:
Memorial Sloan-Kettering Cancer Center
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
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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.
| Condition | Intervention | Phase |
|---|---|---|
|
Liver Cancer |
Dietary Supplement: Sho-saiko-to |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Sho-Saiko-To After Ablation for Non-Resectable Hepatocellular Carcinoma (HCC): A Phase II Trial With Historical Control |
Resource links provided by NLM:
Further study details as provided by Memorial Sloan-Kettering Cancer Center:
| Study Start Date: | January 2001 |
| Primary Completion Date: | January 2006 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00040898
Locations
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
| Study Chair: | Ronald DeMatteo, MD | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00040898 History of Changes |
| Other Study ID Numbers: | 01-002, P30CA008748, MSKCC-01002, NCI-G02-2084 |
| Study First Received: | July 8, 2002 |
| Last Updated: | January 17, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Memorial Sloan-Kettering Cancer Center:
|
localized unresectable adult primary liver cancer advanced adult primary liver cancer recurrent adult primary liver cancer adult primary hepatocellular carcinoma |
Additional relevant MeSH terms:
|
Liver Neoplasms Carcinoma, Hepatocellular Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases |
Liver Diseases Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
ClinicalTrials.gov processed this record on May 21, 2013