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

NCT00471484 | Unknown Phase 2

• 5 other identifiers: CDR0000543536SINGAPORE-OC-GI-01-06SINGAPORE-IRB-06-16-HEPSINGAPORE-CTC0600327SPRI-SINGAPORE-OC-GI-01-06
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Liver Cancer

Keywords

adult primary hepatocellular carcinoma; localized unresectable adult primary liver cancer; advanced adult primary liver cancer; childhood hepatocellular carcinoma; stage III childhood liver cancer; stage IV childhood liver cancer

Outcome Measures

Primary Outcomes (1)

• Objective tumor response rate as measured by RECIST criteria

Secondary Outcomes (2)

• Serum VEGF levels

• Tissue VEGF expression

Interventions

recombinant interferon alfa-2b BIOLOGICAL

doxorubicin hydrochloride DRUG

fluorouracil DRUG

oxaliplatin DRUG

diagnostic laboratory biomarker analysis OTHER

immunoenzyme technique OTHER

immunohistochemistry staining method OTHER

adjuvant therapy PROCEDURE

biopsy PROCEDURE

neoadjuvant therapy PROCEDURE

therapeutic conventional surgery PROCEDURE

Eligibility Criteria

• Age: 16 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Centre, Singapore: lead

Study Sites (1)

National Cancer Centre - Singapore

Singapore, 169610, Singapore

RECRUITING

Related Publications (1)

• Ang MK, Poon D, Foo KF, Chung YF, Chow P, Wan WK, Thng CH, Ooi L. A new chemoimmunotherapy regimen (OXAFI) for advanced hepatocellular carcinoma. Hematol Oncol Stem Cell Ther. 2008 Jul-Sep;1(3):159-65. doi: 10.1016/s1658-3876(08)50024-0.

  PMID: 20063546 RESULT

MeSH Terms

Conditions

Liver Neoplasms; Carcinoma, Hepatocellular

Interventions

Introns; Doxorubicin; Fluorouracil; Oxaliplatin; Immunoenzyme Techniques; Immunohistochemistry; Chemotherapy, Adjuvant; Biopsy; Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

DNA, Intergenic; Genome Components; Genome; Genetic Structures; Genetic Phenomena; Gene Components; Genes; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Coordination Complexes; Immunoassay; Immunologic Techniques; Investigative Techniques; Molecular Probe Techniques; Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Combined Modality Therapy; Therapeutics; Drug Therapy; Cytodiagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative

Study Officials

• Donald Poon, MD

  National Cancer Centre, Singapore

  STUDY CHAIR

• Kian Fong Foo, MD

  National Cancer Centre, Singapore

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 8, 2007
• First Posted: May 10, 2007
• Study Start: March 1, 2007
• Last Updated: June 22, 2011

Record last verified: 2008-11

Locations

SG (1)