Status:
UNKNOWN
Combination Chemotherapy and Interferon Alfa-2b in Treating Patients With Nonmetastatic Liver Cancer That Cannot Be Removed by Surgery
Lead Sponsor:
National Cancer Centre, Singapore
Conditions:
Liver Cancer
Eligibility:
All Genders
16-75 years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, doxorubicin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them fro...
Detailed Description
OBJECTIVES: Primary * Determine the response rate in patients with unresectable, nonmetastatic hepatocellular carcinoma treated with neoadjuvant oxaliplatin, doxorubicin hydrochloride, fluorouracil,...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed hepatocellular carcinoma
- Advanced, unresectable, nonmetastatic disease
- Multifocal disease within the same lobe of the liver allowed
- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
- No intractable ascites that cannot be controlled by medical therapy
- No extrahepatic metastases
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy \> 3 months
- WBC ≥ 3,000/mm³
- ANC ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 9 g/dL
- Bilirubin ≤ 2.9 mg/dL
- AST and ALT ≤ 5 times upper reference range (URR)
- Albumin \> 30 g/L
- Creatinine ≤ 1.5 times URR
- Creatinine clearance \> 50 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 6 months after completion of study therapy
- No other prior malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix
- No concurrent substantial medical illness, such as cardiac or renal disease
- MUGA heart study normal
- No history of allergic reactions attributed to compounds of similar chemical or biological composition used in the study
- No history of autoimmune disease
- No thyroid dysfunction
- No active hepatitis B or C flare or chronic active hepatitis
- Hepatitis B surface antigen (HBsAg) status known
- If HBsAg is negative, anti-HBc antibodies should be tested; if anti-HBc is positive, then hepatitis B virus (HBV) DNA detection should be performed to discern presence of mutant HBV carriage
- No alcohol or drug abuse
- No concurrent uncontrolled illness including, but not limited to, any of the following:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- No psychiatric illness or social situation that would preclude study compliance
- Patients with a history of depression or psychiatric disorders are ineligible
- PRIOR CONCURRENT THERAPY:
- No prior chemotherapy and/or radiotherapy
- No other concurrent investigational agents
Exclusion
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00471484
Start Date
March 1 2007
Last Update
June 22 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
National Cancer Centre - Singapore
Singapore, Singapore, 169610