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

NCT00282100 | Unknown Phase 2

• 1 other identifier: JS0414
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cancer

Outcome Measures

Primary Outcomes (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.

  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.

  Minimum 2 years

Study Arms (1)

Gefitinib (Iressa)

EXPERIMENTAL

Open label single arm study of Gefitinib (Iressa) 250mg daily as adjuvant therapy in patients with resectable Hepatocellular Carcinoma

Drug: Gefetinib (Iressa)

Interventions

Gefetinib (Iressa) DRUG

Gefitinib (Iressa)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Tan Tock Seng Hospital: lead
• Singapore Cancer Syndicate.: collaborator
• AstraZeneca: collaborator

Study Sites (1)

Tan Tock Seng Hospital

Singapore, 308433, Singapore

Location

MeSH Terms

Conditions

Liver Neoplasms

Interventions

Gefitinib

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Alex Chang, M.D.

  Tan Tock Seng Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2006
• First Posted: January 25, 2006
• Study Start: December 1, 2005
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: April 16, 2019

Record last verified: 2019-04

Locations

SG (1)