Status:
COMPLETED
Sorafenib Plus Tegafur/Uracil (UFUR®) for Hepatocellular Carcinoma (HCC)
Lead Sponsor:
National Taiwan University Hospital
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The prognosis for patients with metastatic or locally advanced hepatocellular carcinoma (HCC) is poor. The role of conventional systemic chemotherapy has been very limited because most chemotherapeuti...
Detailed Description
The prognosis for patients with metastatic or locally advanced hepatocellular carcinoma (HCC) is poor. The role of conventional systemic chemotherapy has been very limited because most chemotherapeuti...
Eligibility Criteria
Inclusion
- Age \> 18 years;
- ECOG PS 0-2;
- Histologically or cytologically documented unresectable and/or metastatic HCC;
- Measurable disease by RECIST criteria;
- Previous local therapy completed \> 6 weeks;
- Any acute toxicity (CTC-AE) \< grade 1;
- Child-Pugh A;
- Liver transaminases ≤ 5 x ULN;
- Albumin ≥ 2.8 g/dl;
- Serum total bilirubin ≤ 3 mg/dl;
- INR ≤ 2.3 or PT ≤ 6 seconds above control;
- WBC ≥ 3,000/µl;
- ANC ≥ 1,500/µl;
- Platelets ≥ 100,000/µl;
- Hb ≥ 8.5 g/dl;
- Creatinine ≤ 1.5 x ULN; AND
- Amylase and lipase \< 1.5 x ULN
Exclusion
- Metastatic brain/leptomeningeal tumors;
- Prior or concomitant systemic anti-cancer treatment for HCC, including:
- Systemic chemotherapy (TACE is allowed)
- Immunotherapy
- Hormonal therapy (hormonal therapy used for supportive used is allowed)
- Raf-kinase inhibitors
- MEK inhibitors
- Farnesyl transferase inhibitors
- VEGF/VEGFR- inhibitors or other anti-angiogenesis agents
- Investigational anti-cancer agents
- Severe and/or uncontrolled medical conditions:
- Uncontrolled high blood pressure
- History of poor compliance with anti-hypertensive agents
- Active or uncontrolled infection
- Unstable angina
- CHF
- MI or CVA \< 6 months
- GI bleeding \< 30 days
- Unable to take oral medications
- Severe renal impairment which requires dialysis; proteinuria \> grade 2;
- BMT or stem cell rescue \< 4 months; organ transplant;
- HIV infection;
- Major surgical procedure, open biopsy, or significant traumatic injury \< 4 weeks or those who receive minor surgical procedures (e.g. core biopsy or fine needle aspiration) within 2 weeks;
- Receive central venous line placement within 7 days;
- Patients who anticipate receiving major surgery during the course of the study;
- Use rifampin, St. John's Wort \[Hypericum perforatum\];
- Patients taking narrow therapeutic index medications will be monitored closely. These include warfarin, phenytoin, quinidine, carbamazepine, phenobarbital, cyclosporine, and digoxin; OR
- Patients for whom tegafur is contra-indicated
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2009
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00464919
Start Date
April 1 2007
End Date
March 1 2009
Last Update
July 7 2009
Active Locations (1)
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1
National Taiwan University Hospital
Taipei, Taiwan, 100