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Adult Primary Hepatocellular CarcinomaPhase 2NCT00047333

Erlotinib in Treating Patients With Liver Cancer That Cannot be Surgically Removed

A Phase 2 study testing erlotinib hydrochloride, laboratory biomarker analysis and pharmacological study 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.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Phase II trial to study the effectiveness of erlotinib in treating patients who have liver cancer that cannot be surgically removed. Erlotinib 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?
erlotinib hydrochloride, laboratory biomarker analysis and pharmacological study
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteUnited States
Study dates
Aug 2002to Jan 2006
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

  • Histologically confirmed hepatocellular carcinoma (HCC)not amenable to curative resection
  • No fibrolamellar HCC
  • No prior therapy for HCC, including systemic chemotherapy, hepatic arterial infusion of chemotherapeutic agents or irradiated microspheres, and epidermal growth factor receptor-targeting agents
  • The following prior therapies are allowed provided previously treated lesions remain separate from those to be evaluated in present study
  • Surgery
  • Liver-directed therapy (e.g., radiofrequency ablation, transarterial embolization/chemoembolization, or percutaneous ethanol injection)
Show all 44Show fewer
  • At least 1 unidimensionally measurable lesion
  • At least 20 mm by conventional techniques
  • Must have paraffin tissue block or unstained slides from biopsy or surgical specimen
  • No known brain metastases
  • No ascites that are refractory to conservative management (e.g., sodium restriction to 50 mEq/day dietary sodium and fluid restrictions and/or diuretics)
  • Performance status - ECOG 0-2
  • At least 16 weeks
  • Granulocyte count at least 1,500/mm^3
  • Platelet count at least 60,000/mm^3
  • Hemoglobin at least 10 g/dL
  • Bilirubin no greater than 1.8 mg/dL
  • Albumin at least 2.5 g/dL
  • AST/ALT no greater than 5 times upper limit of normal
  • PT no greater than 1-3 seconds over normal
  • No decompensated liver disease
  • No jaundice
  • No portosystemic encephalopathy (evidenced by confusion, asterixis, significant sleep disturbance, or hypothermia less than 36º Celsius)
  • No hyponatremia with sodium less than 125 mEq/L
  • No portal hypertension with bleeding esophageal or gastric varices within the past 3 months
  • Creatinine no greater than 2 mg/dL
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • No gastrointestinal tract disease resulting in an inability to take oral medication or requirement for IV alimentation
  • No active peptic ulcer disease
  • No abnormalities of the cornea (e.g., dry eye syndrome or Sjögren's syndrome)
  • No congenital abnormality (e.g., Fuch's dystrophy)
  • No other uncontrolled concurrent illness that would preclude study participation
  • No ongoing or active infection
  • No psychiatric illness or social situation that would preclude study compliance
  • No other malignancy within the past 5 years except nonmelanoma skin cancer
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No prior surgical therapy affecting absorption
  • More than 30 days since prior investigational agents
  • No concurrent commercial or other investigational anticancer agents or therapies
  • No concurrent combination antiretroviral therapy for HIV-positive patients

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • M D Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: A Phase 2 Open-Label Study Of OSI-774 (NSC 718781) In Unresectable Hepatocellular Carcinoma

Phase II trial to study the effectiveness of erlotinib in treating patients who have liver cancer that cannot be surgically removed. Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth

Read the detailed description

PRIMARY OBJECTIVES:

  1. To assess progression-free survival (PFS) measured at 16 weeks following initiation of once daily continuous oral therapy with OSI-774 in patients with unresectable hepatocellular carcinoma.

SECONDARY OBJECTIVES:

  1. To assess objective response rate, rate and duration of stable disease, time to progression, median and overall survival in this patient population, and any changes in tumor perfusion based on functional CT imaging.

II. To correlate response with patient characteristics including: age, disease stage (TNM, Okuda [6]), viral hepatitis status, pathologic grade of cirrhosis, Childs-Pugh status, Performance Status, serum values of: alpha feto-protein, bilirubin, transaminases, albumin; EGFR expression score by IHC; and development of skin rash during therapy.

III. To determine the pharmacokinetic and pharmacodynamic profile of OSI-774 in this patient population.

IV. To determine the safety and tolerability of OSI-774 in this patient population.

OUTLINE: Patients are stratified according to epidermal growth factor receptor expression (low, 0-1+ vs high, 2-3+).

Patients receive oral erlotinib once daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months.

Being tested
erlotinib hydrochloride, laboratory biomarker analysis, pharmacological study
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

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

  • erlotinib hydrochlorideDrug

    Also called CP-358,774, erlotinib, OSI-774

    Given PO

  • laboratory biomarker analysisOther

    Correlative studies

  • pharmacological studyOther

    Also called pharmacological studies

    Correlative studies

Study groups in NCT00047333
Study groupRoleWhat they receive
Treatment (erlotinib hydrochloride)ExperimentalPatients receive oral erlotinib once daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Receives: Drug: erlotinib hydrochloride; Other: laboratory biomarker analysis; Other: pharmacological study

What is being measured

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

  1. Progression-free survival

    Summarized by Kaplan-Meier curves, from which medians and progression-free survival can be attained.

    Measured: Time from initiation of therapy until documented disease progression, assessed at 16 weeks

Secondary outcomes (5)

  1. Objective response rate

    Summarized by estimates and standard errors.

    Measured: Up to 4 years

  2. Rate of stable disease

    Summarized by estimates and standard errors.

    Measured: Up to 4 years

  3. Duration of stable disease

    Summarized by Kaplan-Meier curves, from which medians and overall duration of stable disease can be attained.

    Measured: From the start of the treatment until the criteria for progression are met, assessed up to 4 years

  4. Time to progression

    Summarized by Kaplan-Meier curves, from which medians and time to progression can be attained.

    Measured: Up to 4 years

  5. Overall survival

    Summarized by Kaplan-Meier curves, from which medians and overall survival can be attained.

    Measured: Up to 4 years

Timeline

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

  1. First posted27 Jan 2003 (estimated)
  2. Study startAug 2002
  3. Primary completionJan 2006

Why it stopped: Administratively complete.

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
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00047333
Sponsor's protocol ID
NCI-2012-02498
Other IDs
ID02-008, CDR0000257665
Status last verified
Jan 2013
First submitted
3 Oct 2002
Last updated
23 Jan 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing erlotinib hydrochloride, laboratory biomarker analysis and pharmacological study 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 44 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: stopped early, as of the sponsor's last update on 23 Jan 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 was stopped early (reason given: Administratively complete.). Results are not available in the source record.

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 (time frame: Time from initiation of therapy until documented disease progression, assessed at 16 weeks). 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 NCT00047333.

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 23 Jan 2013.

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