UFUR Plus Thalidomide for Advanced Hepatocellular Carcinoma

NCT00519688 | Completed Phase 2

• 2 other identifiers: 940813TTY-TU0510
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

We hypothesize that combination of tegafur/uracil(UFUR) and thalidomide, both of which have been shown to be active in some HCC patients,may be a highly useful regimen for the treatment of advanced HCC. There are several rationales underlying this combination. First, anti-angiogenesis therapy may improve the efficacy of chemotherapy by normalizing the abnormal vasculature in tumors, and thus improving the delivery of chemotherapeutic agents to the tumor cells. Second, chemotherapeutic drugs given in a low-dose, un interrupted, and protracted way can induce anti-tumor effect through the anti-angiogenesis activity (so-called"metronomic chemotherapy"). The efficacy of metronomic chemotherapy can be suppressed by VEGF/VEGFR signaling pathways and thus can bo further potentiated by agents blocking those survival signals of endothelial cell. In this regard, tegafur/uracil appears to be a good candidate for metronomic chemotherapy because tegafur/uracil and its metabolites bave already been shown to inhibit angiogenesis in several pre-clinical models.

Conditions

Hepatocellular Carcinoma

Keywords

tegafur; thalidomide; advanced hepatocellular carcinoma

Outcome Measures

Primary Outcomes (1)

• To evaluate the overall response rate of UFUR and thalidomide in the treatment of advanced HCC by RECIST criteria

  Confirmed response within 4 weeks

Secondary Outcomes (3)

• To determine the disease stabilization rate.

  2 to 3 months

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

  2 to 3 years

• To establish the safety profile.

  Additional 4 months after stopping the investigational drugs

Study Arms (1)

Thalidomide plus Tegafur/Uracil1

EXPERIMENTAL

Thalidomide plus Tegafur/Uracil

Drug: Thalidomide; Drug: Tegafur/Uracil

Interventions

Thalidomide DRUG

100 mg, BID

Also known as: Thado

Thalidomide plus Tegafur/Uracil1

Tegafur/Uracil DRUG

125 mg/m2, based on tegafur, BID

Also known as: UFUR

Thalidomide plus Tegafur/Uracil1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed HCC or HBC/HCV carrier with hepatic tumor of α-FP\>400 Stage IV dis. By AJCC KPS\>70% Age\>18 Liver function reserves:Child-Pugh Class A, ALT\<5xUNL, Bil-T\<1.5xUNL WBC\>4000 or ANC\>1500, PLT\>75K, Cr\<1.5xUNL Previous local therapy completed 6wks

You may not qualify if:

• Concurrent corticosteroids Previous exposure to C/T, Thalidomide CNS metastasis Concomitant illness: active infection, \>NCIG2 neuropathy, Hx of seizures Organ transplantation

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

Department of Oncology , National Taiwan University Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Thalidomide; Tegafur

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Fluorouracil; Uracil; Pyrimidinones; Pyrimidines

Study Officials

• Chih-Hung Hsu, M.D. Ph.D.

  Department of Oncology, National Taiwan University hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2007
• First Posted: August 23, 2007
• Study Start: July 1, 2006
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: October 17, 2011

Record last verified: 2011-10

Locations

TW (1)