Adjuvant Therapy of Gefitinib (Iressa, ZD1839) in Patients With Resectable Hepatocellular Carcinoma

• Status: Unknown status
• Trial end date: 2019-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center; Tan Tock Seng Hospital
• Collaborators: AstraZeneca; Singapore Cancer Syndicate.
• Treatments: Gefitinib

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:

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