Status:
UNKNOWN
A Phase II Study of Tegafur/Uracil (UFUR®)Plus Thalidomide for the Treatment of Advanced or Metastatic Hepatocellular Carcinoma (HCC)
Lead Sponsor:
Far Eastern Memorial Hospital
Conditions:
Carcinoma, Hepatocellular
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Primary objective: To evaluate the overall response rate of tegafur/uracil (UFUR®) and thalidomide in the treatment of advanced or metastatic hepatocellular carcinoma. Secondary objectives: 1. To d...
Detailed Description
Thalidomide is a glutamic acid derivative first developed in 1950s, was marketed as a sedative, tranquilizer, and antiemetic for morning sickness. It was withdrawn from the European and Canadian mark...
Eligibility Criteria
Inclusion
- Histologically proven HCC, or HCC diagnosed by clinical criteria. The clinical diagnosis of HCC should is defined when all the following criteria are met:
- I.Chronic hepatitis B or C virus carrier; II.Presence of hepatic tumor(s) with image findings (sonography, CT scan, etc) compatible with HCC and no evidence of other gastrointestinal tumors; III.A persistent elevation of serum α-fetoprotein (AFP) level of ≧ 400 ng/ml.
- Stage IV diseases by AJCC staging system, or loco-regional diseases which are not operable and not treatable by transarterial (chemo)embolization, percutaenous interventional therapy, or other empirical therapy of higher priority.
- Measurable disease by RECIST criteria.
- Karnofsky performance status ≧ 70%.
- Age of 18 years or older.
- Adequate liver function reserves:
- I.Class A according to Child-Pugh classification; II.Alanine aminotransferase (ALT) ≦ 5 times the ULN; III.Serum total bilirubin ≦ 1.5 times ULN.
- Adequate bone marrow reserves:
- White blood cell (WBC) ≧ 4,000/mm3 or absolute neutrophil count (ANC) ≧ 1,500/mm3;Platelets ≧ 75,000/mm3.
- Serum creatinine ≦ 1.5 times the ULN.
- Previous local therapy, such as radiotherapy, hepatic arterial embolization, radiofrequency ablation, percutaenous inverventional therapy, is allowed if the treatment was completed at least 6 weeks prior to the enrollment.
- Sexually active patients, in conjunction with their partners, must practice birth control during and for 3 months after thalidomide therapy.
- Written informed consent.
Exclusion
- Concurrent radiotherapy, chemotherapy, immunotherapeutic drugs, corticosteroids or other investigational drug(s).
- Previous exposure to the followings:
- I.Cytotoxic chemotherapy; II.Thalidomide.
- CNS metastasis.
- Concomitant diseases that might be aggravated by investigational drugs:
- I.Active or non-controlled infection; II.≧ NCI grade 2 peripheral neuropathy; III.History of seizures within the past 10 years or currently on anticonvulsant medication.
- Organ transplantation.
- Major systemic diseases those are inappropriate for systemic chemotherapy.
- Mental status not fit for clinical trials.
- Inability to take medications orally.
- Pregnant or breast-feeding women.
- Life expectancy less than 3 month.
- Other malignancy with the exception of curatively treated non-melanoma skin cancer or cervical carcinoma in situ, from which the patient has been disease-free for 5 years.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00384800
Start Date
September 1 2006
Last Update
February 9 2009
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Far Eastern Memorial Hospital
Taipei, Ban-Ciao, Taiwan, 220