NCT00071994

Brief Summary

Phase II trial to study the effectiveness of gefitinib in treating patients who have advanced unresectable hepatocellular carcinoma (liver cancer). Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 4, 2003

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 6, 2003

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2004

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2005

Completed
Last Updated

February 27, 2013

Status Verified

February 1, 2013

Enrollment Period

1.2 years

First QC Date

November 4, 2003

Last Update Submit

February 26, 2013

Conditions

Adult Primary Hepatocellular CarcinomaAdvanced Adult Primary Liver CancerLocalized Unresectable Adult Primary Liver CancerRecurrent Adult Primary Liver Cancer

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival rate in patients treated with ZD 1839

    A 4.5-month (PFS) rate of 63% or more will be taken as evidence of activity in this patient population.

    From the date of entry on the study to the appearance of new metastatic lesions or objective tumor progression, assessed up to 4.5 months

Secondary Outcomes (3)

  • Response (CR+PR) measured by RECIST

    Up to 3 years

  • Grade 3 or higher toxicity

    Up to 3 years

  • EGFR expression

    Baseline

Study Arms (1)

Treatment (gefitinib)

EXPERIMENTAL

Patients receive oral gefitinib daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Drug: gefitinibOther: laboratory biomarker analysis

Interventions

gefitinibDRUG

Given orally

Also known as: Iressa, ZD 1839
Treatment (gefitinib)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (gefitinib)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must have advanced unresectable hepatocellular carcinoma based on the following criteria:
  • Histologically or cytologically confirmed, OR
  • Alpha-fetoprotein \> 400 ng if patient is not hepatitis surface antigen positive, OR
  • Alpha-fetoprotein \> 4000 ng if patient is hepatitis surface antigen positive
  • NOTE: If available, tissue should be submitted to assess EGFR/pathway expression
  • Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>= 20 mm with conventional techniques or as \>= 10 mm with spiral CT scan, assessed within 4 weeks prior to randomization/registration
  • Prior use of liver-directed therapy (radio-frequency ablation, cryoablation, percutaneous ethanol injection, chemo-embolization, hepatic artery embolization and hepatic artery infused FUDR) is allowed, provided the patient has either progressive hepatic disease or measurable extrahepatic disease
  • ECOG performance status of 0, 1 or 2
  • Leukocytes \>= 2,000/uL OR
  • Absolute neutrophil count \>= 1,000/uL
  • Platelets \>= 50,000/uL
  • Patients may not have Child Pugh Scale's class C cirrhosis
  • AST (SGOT) =\< 5 x institutional upper limit of normal
  • Total bilirubin =\< 2 x institutional upper limit of normal
  • Creatinine within normal institutional limits OR creatinine clearance \>= 60 mL/min for patients with creatinine levels above institutional normal
  • +17 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eastern Cooperative Oncology Group

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Gefitinib

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Bruce Giantonio

    Eastern Cooperative Oncology Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2003

First Posted

November 6, 2003

Study Start

February 1, 2004

Primary Completion

May 1, 2005

Last Updated

February 27, 2013

Record last verified: 2013-02

Locations

US(1)