18 Years
N/A
Both
Liver Cancer
Trial Information
Hepatocellular carcinoma (HCC) is one of the most common cancers in the world1. HCC risk
increases drastically in patients with chronic hepatitis B infection, hepatitis C infection
or liver cirrhosis. HCC is very prevalent in our region due to endemic hepatitis B
infection and increasing incidence of hepatitis C.
Patients with HCC have very poor prognosis because HCC tumors are usually non-symptomatic.
Most patients will not be diagnosed until the disease has reached an advanced stage.
Chemotherapy may offer palliative benefit to some patients with advanced HCC but has not
been shown to prolong survival in these patients. HCC patients are in need for innovative
and targeted therapies. Therefore, we propose to study gefitinib as an adjuvant therapy in
patients with resected HCC.
Gefitinib blocks the function of epidermal growth factor receptor which is a key factor in
stimulating liver cancer growth. In mice, gefitinib has been shown to reduce the size of
liver cancer. It also had anti tumor activity in patients with various cancers including
HCC. Gefitinib can relieve disease-related symptoms in these patients. Overall, gefitinib
is a very well tolerated treatment and is suitable for long-term use.
At the time of diagnosis and surgical evaluation, patients with resectable hepatocellular
carcinoma will be asked to participate in this study.Patients will be registered after
consent form is obtained. Patient is asked to donate tumor tissues, urine and blood
samples.Tumorand normal specimens are collected at the time of surgery. After patient
recovers from surgery (4-6 weeks) and fullfills the eligiblity, patient will receive
gefitinib 250 mg p.o. daily for 6 months.
Patient will remain on study till completion of treatment. The following are conditions when
your study doctor will remove you from the study or stop the therapy:
1. Interruption of treatment for 4 consecutive weeks due to side effects, which do not
resolve.
2. withdraw of consent by patient. ii. Your disease becomes worse. iii. New information
that gefitinib treatment is harmful to patients has become available.
Patient will be evaluated at one month, 3 months and 6 months on gefitinib. After that,
evaluate patient at least every 3 months for first 2 years, then every 6 months for next 3
years, then yearly afterwards. Draw blood and store sera and urine at the same interval
until relapse and/or death. Conduct correlative studies of urine, serum and tumor tissue
with clinical outcome.
Inclusion Criteria:
Pathologically newly diagnosis HCC, which is deemed resectable and resected.
Patient has to start gefitinib within 6 weeks of hepatic resection with full recovery.
Patients with positive resection margin or minimal residual disease (<0.5 cm) are also
eligible.
ECOG performance status (PS) 0, 1 or 2
Patient must recover fully from hepatic resection ANC > 1,500/uL SGOT < 5 x UNL (upper
normal limits) Plt > 75,000/uL Bilirubin < 2 x UNL Serum albumin ≥ 2.5g/dL
Creatinine < 1.5 mg/dl or 125 u/L, alpha fetoprotein < 50 ug/L
Signed informed consent
Age > 18
No space occupying lesion on CT scan of the liver i.e. normal CT scan post-resection.
Small lesion in the liver after resection can be ablated by alcohol injection or radio
frequency ablation and can make patient eligible.
Negative pregnancy test of the blood within 7 days of starting treatment in female patient
of childbearing potential.
No prior systemic therapy or I131 or chemoembolization treatment after surgery.
Can take or swallow medication orally i.e. no chronic or persistent nausea and vomiting
No other malignancy except for adequately treated basal cell or squamous cell skin cancer
or cervical cancer in-situ.
No active infection, symptomatic CHF, unstable angina, uncontrolled cardiac arrhythmia and
psychiatric disorder.
No concomitant medications such as phenytoin, carbamazepine, rifampicin, barbiturates,
ketoconazole and itraconazole, which are potent inducers of CYP3A4 or potent inhibitors of
CYP3A4.
Patient is not taking St. John's Wort.
Exclusion Criteria:
-
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
To study the changes of selected genetic or protein markers through the treatment and find out whether some of them can be potential biomarkers for disease relapse.
Principal Investigator
Alex Chang, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
CEO and Medical Director Of Johns Hopkins Singapore International Medical Center
Authority:
United States: Institutional Review Board
Study ID:
JS0414
NCT ID:
NCT00282100
Start Date:
December 2005
Completion Date:
December 2012
Related Keywords:
- Liver Cancer
- Liver Neoplasms
- Carcinoma, Hepatocellular
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