Status:
UNKNOWN
Adjuvant Therapy of Gefitinib (Iressa, ZD1839) in Patients With Resectable Hepatocellular Carcinoma
Lead Sponsor:
Tan Tock Seng Hospital
Collaborating Sponsors:
Singapore Cancer Syndicate.
AstraZeneca
Conditions:
Liver Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
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....
Eligibility Criteria
Inclusion
- 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
- \-
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2019
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00282100
Start Date
December 1 2005
End Date
September 1 2019
Last Update
April 16 2019
Active Locations (1)
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1
Tan Tock Seng Hospital
Singapore, Singapore, 308433