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Trial Title:
Combination Chemotherapy and Interferon Alfa-2b in Treating Patients With Nonmetastatic Liver Cancer That Cannot Be Removed by Surgery
NCT ID:
NCT00471484
Condition:
Liver Cancer
Conditions: Official terms:
Liver Neoplasms
Interferons
Interferon-alpha
Interferon alpha-2
Doxorubicin
Liposomal doxorubicin
Oxaliplatin
Fluorouracil
Conditions: 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
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
recombinant interferon alfa-2b
Intervention type:
Drug
Intervention name:
doxorubicin hydrochloride
Intervention type:
Drug
Intervention name:
fluorouracil
Intervention type:
Drug
Intervention name:
oxaliplatin
Intervention type:
Other
Intervention name:
diagnostic laboratory biomarker analysis
Intervention type:
Other
Intervention name:
immunoenzyme technique
Intervention type:
Other
Intervention name:
immunohistochemistry staining method
Intervention type:
Procedure
Intervention name:
adjuvant therapy
Intervention type:
Procedure
Intervention name:
biopsy
Intervention type:
Procedure
Intervention name:
neoadjuvant therapy
Intervention type:
Procedure
Intervention name:
therapeutic conventional surgery
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.
Detailed description:
OBJECTIVES:
Primary
- Determine the response rate in patients with unresectable, nonmetastatic
hepatocellular carcinoma treated with neoadjuvant oxaliplatin, doxorubicin
hydrochloride, fluorouracil, and recombinant interferon alfa-2b.
Secondary
- Determine the overall survival of patients treated with this regimen.
- Determine the progression-free survival of patients treated with this regimen.
- Determine the rate of conversion to resectability of tumor in patients treated with
this regimen.
- Determine the toxicity profile of this regimen in these patients.
- Assess the quality of life of patients treated with this regimen.
- Correlate changes in serological markers of angiogenesis before and after treatment
with clinical outcome in these patients.
- Correlate and validate the use of functional imaging before and after treatment with
clinical outcome in these patients.
OUTLINE: Patients receive neoadjuvant OXAFI therapy comprising oxaliplatin IV and
doxorubicin hydrochloride IV on days 1, 8 and 15; fluorouracil IV continuously on days
1-28; and recombinant interferon alfa-2b subcutaneously three times weekly in weeks 1-4.
Treatment repeats every 28 days for up to 6 courses in the absence of disease progression
or unacceptable toxicity. Patients receive at least 2 courses of neoadjuvant therapy
before undergoing evaluation for response. Patients whose disease becomes resectable
after achieving a complete or partial response proceed to surgery. Patients whose disease
remains unresectable are reevaluated until their disease either becomes resectable, they
complete neoadjuvant therapy, or they meet discontinuation criteria.
At least 2 weeks after receiving neoadjuvant therapy, patients whose disease is
resectable undergo surgery for potentially complete resection of their tumors with
curative intent. Patients who achieve complete resection proceed to adjuvant therapy.
At least 4 weeks after surgery, patients may restart OXAFI as adjuvant therapy, provided
they have fully recovered from surgery and have received fewer than 6 courses of
neoadjuvant therapy. Adjuvant therapy repeats every 28 days for a total of 6 courses
(including neoadjuvant OXAFI) in the absence of disease progression or unacceptable
toxicity.
Patients undergo blood and tissue collection at baseline and periodically during study
for evaluation of circulating and tissue biomarkers of angiogenesis. Serum from venous
blood samples is analyzed for concentration of VEGF by ELISA. Tumor tissue obtained
before and after treatment is examined for tumor VEGF expression, microvessel density,
and cellular proliferation by IHC.
Patients complete quality of life questionnaires at baseline, monthly during study
treatment, after course 6 of neoadjuvant chemotherapy, or upon discontinuation of study
treatment.
Patients are followed periodically for up to 5 years after curative resection of their
tumors.
PROJECTED ACCRUAL: A total of 54 patients will be accrued for this study.
Criteria for eligibility:
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
Gender:
All
Minimum age:
16 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
National Cancer Centre - Singapore
Address:
City:
Singapore
Zip:
169610
Country:
Singapore
Status:
Recruiting
Contact:
Last name:
Donald Poon, MD
Phone:
65-6-436-8000
Start date:
March 2007
Lead sponsor:
Agency:
National Cancer Centre, Singapore
Agency class:
Other
Source:
National Cancer Institute (NCI)
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00471484