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Adult Primary Cholangiocellular CarcinomaPhase 2NCT00033462

Erlotinib in Treating Patients With Unresectable Liver, Bile Duct, or Gallbladder Cancer

A Phase 2 study testing erlotinib hydrochloride and laboratory biomarker analysis in people with Adult Primary Cholangiocellular Carcinoma and Adult Primary Hepatocellular Carcinoma, 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 erlotinib in treating patients who have unresectable liver, bile duct, or gallbladder cancer. Biological therapies such as erlotinib may interfere with the growth of cancer cells and slow the growth of the tumor. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
erlotinib hydrochloride 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
78 participants
Where
1 siteUnited States
Study dates
Mar 2002to Nov 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 or cytologically confirmed hepatocellular carcinoma (HCC) or biliary carcinoma that is surgically unresectable; exception: for surgically unresectable HCC, a hypervascular mass on CT and an AFP > 100ng/mL will suffice as noninvasive diagnostic criteria
  • Measurable disease defined as at least one lesion whose longest diameter can be accurately measured as ≥ 2.0 cm
  • Absolute neutrophil count (ANC) ≥ 1500/mm3
  • PLT ≥ 75,000/mm3
  • Total bilirubin ≤ 2 x upper normal limits (UNL)
  • Serum AST ≤ 3 x UNL
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  • Serum ALT ≤ 3 x UNL
  • Serum creatinine ≤ 2 mg/dL
  • Serum albumin ≥ 2.5 g/dL
  • Patients not receiving anticoagulation: INR ≤ 1.5
  • ECOG performance status (PS) 0, 1, or 2
  • Estimated life expectancy ≥ 3 months
  • Capable of understanding the investigational nature, potential risks and benefits of the study and able to provide written informed consent
  • HCC Patients Only: Child-Pugh classification of A or B
  • For patients having prior cryotherapy, radiofrequency ablation, ethanol injection, or photodynamic therapy, the following criteria must be met:
  • > 6 weeks has elapsed since that therapy
  • Indicator lesion(s) is/are outside the area of prior treatment or, if the only indicator lesion is inside the prior treatment area, there must be clear evidence of disease progression associated with that lesion
  • Edges of the indicator lesion are clearly distinct on CT scanning

Who cannot join

  • Ampulla of Vater tumors
  • Any of the following as this regimen may be harmful to a developing fetus or nursing child:
  • Pregnant women
  • Breastfeeding women
  • Men or women of childbearing potential or their sexual partners who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device [IUD], surgical sterilization, subcutaneous implants, or abstinence, etc.)
  • NOTE: The effects of OSI-774 on the developing human fetus at the recommended therapeutic dose are unknown
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  • Any of the following:
  • > 1 prior systemic anticancer therapy; Note: Chemoembolization will be considered as one prior chemotherapeutic regimen.
  • Prior EGFR targeting therapy
  • Nitrosoureas or mitomycin C ≤6 weeks prior to study entry
  • Other chemotherapy ≤4 weeks prior to study entry
  • Immunotherapy ≤ 4 weeks prior to study entry
  • Biologic therapy ≤ 4 weeks prior to study entry
  • Radiation therapy ≤ 4 weeks prior to study entry
  • Prior cryotherapy, radiofrequency ablation, ethanol injection or photodynamic therapy ≤6 weeks prior to study entry
  • Failure to fully recover from adverse effects of prior therapies regardless of interval since last treatment
  • Other concurrent chemotherapy, immunotherapy, radiotherapy, or any other therapy or supportive care considered investigational
  • Major surgery, or significant traumatic injury occurring ≤ 3 weeks prior to planned treatment start date
  • Any of the following:
  • Gastrointestinal tract disease resulting in an inability to take oral medication
  • Requirement for IV alimentation
  • Prior procedures affecting absorption
  • Active peptic ulcer disease
  • History of other malignancy other than hepatocellular or biliary carcinoma within the previous 3 years, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma of the cervix
  • Known abnormalities of the cornea such as:
  • History of dry eye syndrome or Sjorgen's syndrome
  • Congenital abnormality (e.g., Fuch's dystrophy)
  • Abnormal slit-lamp examination using a vital dye (e.g., fluorescein, Bengal-Rose)
  • Abnormal corneal sensitivity test (Schirmer test or similar tear production test)
  • Known CNS metastases; NOTE: These patients are excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
  • Uncontrolled intercurrent illness including, but not limited to:
  • Ongoing or active infection
  • Symptomatic congestive heart failure
  • Unstable angina pectoris, cardiac arrhythmia
  • Psychiatric illness/social situations that would limit compliance with study requirements
  • HIV-positive patients receiving combination anti-retroviral therapy; NOTE: Patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy; these patients are excluded from the study because of possible pharmacokinetic interactions with OSI-774; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mayo Clinic

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: A Phase II Trial of OSI-774 in Patients With Hepatocellular or Biliary Carcinoma

Phase II trial to study the effectiveness of erlotinib in treating patients who have unresectable liver, bile duct, or gallbladder cancer. Biological therapies such as erlotinib may interfere with the growth of cancer cells and slow the growth of the tumor.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To evaluate the proportion of patients with unresectable hepatocellular or biliary carcinoma treated with OSI-774 who are progression-free at 24 weeks.

SECONDARY OBJECTIVES:

  1. To evaluate the toxicity profile of this treatment in each of the patient groups.

II. To evaluate the objective response rate of patients with hepatocellular or biliary carcinoma treated with OSI-774.

III. To evaluate overall and progression-free survival. IV. To assess the EGFR protein levels and explore their association with clinical outcome.

OUTLINE: This is a multicenter study. Patients are assigned to 1 of 2 groups according to cancer type (hepatocellular vs biliary).

Patients receive oral erlotinib once daily. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for up to 3 years.

Being tested
erlotinib hydrochloride, laboratory biomarker analysis
Medical subject headings
Carcinoma, Hepatocellular, Bile Duct Neoplasms, Gallbladder Neoplasms

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 orally

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00033462
Study groupRoleWhat they receive
Arm IExperimentalPatients receive oral erlotinib once daily. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
Receives: Drug: erlotinib hydrochloride; Other: laboratory biomarker analysis

What is being measured

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

  1. Proportion of patients who are progression-free at 24 weeks

    Confidence intervals for the true PFR will be calculated using the methods of Duffy-Santner.

    Measured: At 24 weeks

Secondary outcomes (5)

  1. Objective response, defined by the RECIST criteria in terms of tumor/lesion size and change

    Measured: Up to 3 years

  2. Overall survival

    The distribution of survival time will be estimated using the method of Kaplan-Meier.

    Measured: Time from registration to death due to any cause, assessed up to 3 years

  3. Time to disease progression

    The distribution of time to progression will be estimated using the method of Kaplan-Meier.

    Measured: Time from registration to documentation of disease progression, assessed up to 3 years

  4. EGFR protein levels

    We will evaluate these EGFR protein levels and explore their association with clinical outcome.

    Measured: Baseline

  5. Overall response rate in EGFR positive patients

    Analyses will be done independently on patients from each patient group. Corresponding 95% confidence intervals will also be calculated.

    Measured: Up to 3 years

Timeline

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

  1. First posted6 Jun 2003 (estimated)
  2. Study startMar 2002
  3. Primary completionNov 2006

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
78 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00033462
Sponsor's protocol ID
NCI-2012-02797
Other IDs
MC0152, 5429, N01CM17104
Status last verified
Jun 2013
First submitted
9 Apr 2002
Last updated
4 Jun 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing erlotinib hydrochloride and laboratory biomarker analysis in people with Adult Primary Cholangiocellular Carcinoma and Adult Primary Hepatocellular Carcinoma, 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 18 inclusion and 36 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 4 Jun 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?

Proportion of patients who are progression-free at 24 weeks (time frame: At 24 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 NCT00033462.

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 4 Jun 2013; AzTrials last refreshed its copy on 8 Nov 2026.

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