NCT00384800

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. 1.To determine the disease stabilization rate;
  2. 2.To assess the progression-free survival and overall survival;
  3. 3.To establish the safety profile;
  4. 4.To evaluate the changes of circulating factors indicating the angiogenesis activity and their correlation with objective tumor response.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 4, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 6, 2006

Completed
Last Updated

February 9, 2009

Status Verified

March 1, 2006

First QC Date

October 4, 2006

Last Update Submit

February 6, 2009

Conditions

Carcinoma, Hepatocellular

Outcome Measures

Primary Outcomes (2)

  • Primary Objective

  • To assess the overall response rate of tegafur/uracil (UFUR®) and thalidomide in the treatment of advanced or metastatic hepatocellular carcinoma.

Secondary Outcomes (5)

  • Secondary Objectives

  • To determine the disease stabilization rate (CR+PR+SD).

  • To assess the progression-free survival and overall survival.

  • To establish the safety profile.

  • To evaluate the changes of circulating factors indicating the angiogenesis activity and their correlation with objective tumor response.

Interventions

Thalidomide(THADO), Tegafur/Uracil(UFUR)DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Far Eastern Memorial Hospital

Taipei, Ban-Ciao, 220, Taiwan

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Tegafur

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

FluorouracilUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Kun Huei Yeh, Ph.D.

    Far Eastern Memorial Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kun Huei Yeh, Ph.D.

CONTACT

886-2-89667000khyeh@mail.femh.org.tw

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 4, 2006

First Posted

October 6, 2006

Study Start

September 1, 2006

Last Updated

February 9, 2009

Record last verified: 2006-03

Locations

TW(1)