Liver CancerPhase 2NCT00282100
Adjuvant Therapy of Gefitinib (Iressa, ZD1839) in Patients With Resectable Hepatocellular Carcinoma
A Phase 2 study testing Gefetinib (Iressa) in people with Liver Cancer, run by Tan Tock Seng Hospital at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cancer
- What is being tested?
- Gefetinib (Iressa)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSingapore
- Study dates
- Dec 2005to Sep 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of Adjuvant Therapy of Gefitinib (Iressa, ZD1839) in Patients With Resectable Hepatocellular Carcinoma
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.
Read the 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.Tumor and normal specimens are collected at the time of surgery. After patient recovers from surgery (4-6 weeks) and fulfills the eligibility, 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.
- Conditions
- Liver Cancer
- Being tested
- Gefetinib (Iressa)
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gefetinib (Iressa)Drug
| Study group | Role | What they receive |
|---|---|---|
| Gefitinib (Iressa) | Experimental | Open label single arm study of Gefitinib (Iressa) 250mg daily as adjuvant therapy in patients with resectable Hepatocellular Carcinoma Receives: Drug: Gefetinib (Iressa) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Minimum 2 years
Secondary outcomes (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.
Measured: Minimum 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2006 (estimated)
- Study startDec 2005
- Primary completionSep 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tan Tock Seng Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Singapore Cancer Syndicate., AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Alex Chang, M.D., Principal investigator, Tan Tock Seng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00282100
- Sponsor's protocol ID
- JS0414
- Status last verified
- Apr 2019
- First submitted
- 24 Jan 2006
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Adjuvant Therapy of Gefitinib (Iressa, ZD1839) in Patients With Resectable Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT00282100
- Acronym / sponsor ID
- JS0414
- Conditions
- Liver Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tan Tock Seng HospitalUniversity, hospital or other
- Collaborators
- Singapore Cancer Syndicate., AstraZeneca
- Study start
- Dec 2005 (actual)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 25 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.Tumor and normal specimens are collected at the time of surgery. After patient recovers from surgery (4-6 weeks) and fulfills the eligibility, 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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gefitinib (Iressa) | Experimental | Drug: Gefetinib (Iressa)Open label single arm study of Gefitinib (Iressa) 250mg daily as adjuvant therapy in patients with resectable Hepatocellular Carcinoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gefetinib (Iressa) | Drug | Gefitinib (Iressa) |
Primary outcome
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.
Time frame: Minimum 2 years
1 secondary outcome
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.
Time frame: Minimum 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alex Chang, M.D. principal investigator
Tan Tock Seng Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gefetinib (Iressa) in people with Liver Cancer, run by Tan Tock Seng Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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. (time frame: Minimum 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2019.