Combination Chemotherapy and Interferon Alfa-2b in Treating Patients With Nonmetastatic Liver Cancer That Cannot Be Removed by Surgery

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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 from dividing. Interferon alfa may interfere with the growth of tumor cells. Giving combination chemotherapy together with interferon alfa may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with interferon alfa-2b works in treating patients with nonmetastatic liver cancer that cannot be removed by surgery.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Centre, Singapore
• Treatments: Doxorubicin; Fluorouracil; Interferon alpha-2; Interferon-alpha; Interferons; Liposomal doxorubicin; Oxaliplatin

Criteria

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