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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
Sponsor:
Collaborators:
Singapore Cancer Syndicate.
AstraZeneca
Information provided by:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief Summary:
This research is being done to find how soon the liver cancer may come back and whether proteins or genes in tumor, blood or urine can give us clues of early recurrence.

Condition or disease Intervention/treatment Phase
Liver Cancer Drug: Iressa Phase 2

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : December 2005
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer
Drug Information available for: Gefitinib




Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:


Information from the National Library of Medicine

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


Locations
Singapore
Johns Hopkins Singapore International Center
Singapore, Singapore, 308433
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Singapore Cancer Syndicate.
AstraZeneca
Investigators
Principal Investigator: Alex Chang, M.D. CEO and Medical Director Of Johns Hopkins Singapore International Medical Center

Responsible Party: Alex Y. Chang, M.D., Johns Hopkins Singapore International Medical Centre
ClinicalTrials.gov Identifier: NCT00282100     History of Changes
Obsolete Identifiers: NCT00228501
Other Study ID Numbers: JS0414
First Posted: January 25, 2006    Key Record Dates
Last Update Posted: December 17, 2008
Last Verified: December 2008

Additional relevant MeSH terms:
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases
Gefitinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action