A Phase II Study of Tegafur/Uracil (UFUR®)Plus Thalidomide for the Treatment of Advanced or Metastatic Hepatocellular Carcinoma (HCC)

Launched by FAR EASTERN MEMORIAL HOSPITAL · Oct 4, 2006

Keywords

ClinConnect Summary

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It was withdrawn from the European and Canadian markets in early 1960s because of its teratogenic effects . It was not until 1998 when FDA approved thalidomide in the US for the treatment of erythema nodosum leprosum , ENL.

In recent years, thalidomide is emerging as a novel treatment for cancer because of its anti-angiogenic properties. The clinical efficacy has been demonstrated in various types of human cancers, such as myeloma, hormone-refr...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• 1. 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.
• • 2. 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.
• • 3. Measurable disease by RECIST criteria.
• • 4. Karnofsky performance status ≧ 70%.
• • 5. Age of 18 years or older.
• 6. 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.
• 7. Adequate bone marrow reserves:
• • White blood cell (WBC) ≧ 4,000/mm3 or absolute neutrophil count (ANC) ≧ 1,500/mm3;Platelets ≧ 75,000/mm3.
• • 8. Serum creatinine ≦ 1.5 times the ULN.
• • 9. 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.
• • 10. Sexually active patients, in conjunction with their partners, must practice birth control during and for 3 months after thalidomide therapy.
• • 11. Written informed consent.
• Exclusion Criteria:
• • 1. Concurrent radiotherapy, chemotherapy, immunotherapeutic drugs, corticosteroids or other investigational drug(s).
• 2. Previous exposure to the followings:
• • I.Cytotoxic chemotherapy; II.Thalidomide.
• • 3. CNS metastasis.
• 4. 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.
• • 5. Organ transplantation.
• • 6. Major systemic diseases those are inappropriate for systemic chemotherapy.
• • 7. Mental status not fit for clinical trials.
• • 8. Inability to take medications orally.
• • 9. Pregnant or breast-feeding women.
• • 10. Life expectancy less than 3 month.
• • 11. 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.