A Pilot Study of Adjuvant Therapy of Gefitinib (Iressa, ZD1839) in Patients With Resectable Hepatocellular Carcinoma
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|ClinicalTrials.gov Identifier: NCT00282100|
Recruitment Status : Unknown
Verified December 2008 by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
Recruitment status was: Active, not recruiting
First Posted : January 25, 2006
Last Update Posted : December 17, 2008
|Condition or disease||Intervention/treatment||Phase|
|Liver Cancer||Drug: Iressa||Phase 2|
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:
- Interruption of treatment for 4 consecutive weeks due to side effects, which do not resolve.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||December 2005|
|Estimated Study Completion Date :||December 2012|
- 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.
- To evaluate the effect of gefitinib as an adjuvant therapy on recurrence free survival in patients with resectable hepatocellular carcinoma; to evaluate the treatment toxities of genifitib.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00282100
|Johns Hopkins Singapore International Center|
|Singapore, Singapore, 308433|
|Principal Investigator:||Alex Chang, M.D.||CEO and Medical Director Of Johns Hopkins Singapore International Medical Center|