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Adult Primary Hepatocellular CarcinomaPhase 2NCT00071994

Gefitinib in Treating Patients With Advanced Unresectable Hepatocellular Carcinoma (Liver Cancer)

A Phase 2 study testing gefitinib and laboratory biomarker analysis in people with Adult Primary Hepatocellular Carcinoma and Advanced Adult Primary Liver Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
gefitinib and laboratory biomarker analysis
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
59 participants
Where
1 siteUnited States
Study dates
Feb 2004to May 2005
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

  • 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
Show all 32Show fewer
  • 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
  • PT =< 6 seconds over control
  • INR =< 2.3
  • Albumin >= 2.8 g/dL
  • Pregnant women are excluded from this study; sexually active women of child bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) for the duration of their participation in the study; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
  • Women who are breastfeeding a child are not eligible, unless they discontinue the breastfeeding
  • Patients must not have had prior systemic chemotherapy, biologic therapy or antiangiogenesis therapy; prior therapy with interferon alpha or interferon beta for treatment of hepatitis B or C is allowed provided
  • Prior palliative radiotherapy is permissible provided it has been completed 2 weeks from registration and the patient has measurable disease outside the radiation field
  • Patients may not be receiving any other investigational agents
  • Patients must not have a history of other malignancies that are active and require therapy (other than local therapies for non melanoma skin cancers)
  • Patients must not have known brain metastases; their poor prognosis would present challenges and their tendency to develop progressive neurologic dysfunction would confound the evaluation of neurologic and other adverse events
  • Patients must not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to ZD1839
  • Patients must not have had prior treatment with an EGFR inhibitor
  • Patients must not have a history of an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Patients must not be HIV-positive and receiving combination anti-retroviral therapy; this therapy might have possible pharmacokinetic interactions with ZD1839; appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated
  • Patients must not use the following known inducers of CYP3A4: carbamazepine, dexamethasone, ethosuxamide, glucocorticoids, griseofulvin, nafcillin, nelfinavir nevirapine, oxcarbazepine, phenobarbital, phenylbutazone, phenytoin, primidone, progesterone, rifabutin, rifampin, rofecoxib, St John's Wort, sulfadimidine, sulfinpyrazone, troglitazone, efavirenz, modafinil, and rifapentine; drugs that induce CYP3A4 enzymes can cause reductions in ZD1839 plasma concentrations below levels thought to be biologically active
  • Patients must not be candidates for surgical resection or liver transplantation
  • Patients must not have grade 3 or grade 4 encephalopathy

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Eastern Cooperative Oncology Group

    Boston, Massachusetts, 02215

Other trials in United States

About this study

Official title: A Phase II Study of ZD1839 (Iressa, Gefitinib, NSC 715055) in Advanced Unresectable Hepatocellular Carcinoma

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

Read the detailed description

PRIMARY OBJECTIVES:

  1. Evaluate the ability of ZD1839 to improve progression free survival in patients with advanced unresectable hepatocellular carcinoma.

II. Evaluate response rate of ZD1839 in advanced unresectable hepatocellular carcinoma.

III. Evaluate the effect of ZD1839 on measurable disease in patients with unresectable hepatocellular carcinoma.

IV. Evaluate the effect of ZD1839 on serum alpha-fetoprotein levels in patients with abnormal pretreatment serum levels.

  1. Evaluate toxicity of ZD1839 in advanced unresectable hepatocellular carcinoma.

VI. Investigate biologic markers for outcome in patients with unresectable hepatocellular carcinoma treated with ZD1839.

OUTLINE: This is a multicenter study.

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

Patients are followed for 3 years from study entry.

Being tested
gefitinib, laboratory biomarker analysis
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • gefitinibDrug

    Also called Iressa, ZD 1839

    Given orally

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00071994
Study groupRoleWhat they receive
Treatment (gefitinib)ExperimentalPatients receive oral gefitinib daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Receives: Drug: gefitinib; Other: laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

  1. Response (CR+PR) measured by RECIST

    Measured: Up to 3 years

  2. Grade 3 or higher toxicity

    Measured: Up to 3 years

  3. EGFR expression

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2003 (estimated)
  2. Study startFeb 2004
  3. Primary completionMay 2005

Resources

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
59 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00071994
Sponsor's protocol ID
NCI-2012-02948
Other IDs
E1203, U10CA021115, CDR0000335058
Status last verified
Feb 2013
First submitted
4 Nov 2003
Last updated
27 Feb 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing gefitinib and laboratory biomarker analysis in people with Adult Primary Hepatocellular Carcinoma and Advanced Adult Primary Liver Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

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 32 inclusion and 0 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: finished, as of the sponsor's last update on 27 Feb 2013. 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 United States. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Progression-free survival rate in patients treated with ZD 1839 (time frame: 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00071994.

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 27 Feb 2013.

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