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Intraductal Papillary Mucinous Neoplasm of the PancreasPhase 2NCT00482625

Erlotinib Hydrochloride in Treating Patients With Pancreatic Cancer That Can Be Removed by Surgery

A Phase 2 study testing erlotinib hydrochloride, conventional surgery and immunohistochemistry staining method in people with Intraductal Papillary Mucinous Neoplasm of the Pancreas and Recurrent Pancreatic 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

Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving erlotinib hydrochloride before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
erlotinib hydrochloride, conventional surgery and immunohistochemistry staining method
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteUnited States
Study dates
Jun 2007to Sep 2013
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Confirmed IPMN histological diagnosis, endoscopic ultrasound fine needle aspiration (EUS-FNA) core biopsy tissue specimen with plan for pancreatic surgical resection; histological diagnosis should be within 6 months of entry into protocol
  • Patients must have adequate bone marrow function at study entry
  • White blood cell (WBC) > 3,000
  • Platelets > 100,000/mm^3
  • Hemoglobin > 10 g/dL
  • Plasma creatinine of < 1.6 mg/dL
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  • Total bilirubin < 1.5
  • Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 1.5 x upper limit of normal
  • Patients with evidence of obstructive lung disease (forced expiratory volume in one second [FEV1] < 80% predicted and FEV1/forced vital capacity [FVC] ratio < 90% of predicted value) as the etiology of a low diffusing capacity will still be eligible as long as the chest radiograph or computed tomography (CT) does not demonstrate interstitial changes
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Women of child-bearing potential and men taking study drug must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation
  • Ability to understand, as well as sign the written informed consent document
  • If a woman of child-bearing potential, must have a negative pregnancy test prior to study entry; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately

Who cannot join

  • Intake of EGFR antagonist, Erbitux (cetuximab)
  • Previous history of sensitivity to Tarceva (erlotinib hydrochloride), Iressa (gefitinib), or Erbitux, such as a rash that is uncontrollable by topical steroids and/or antibiotics
  • Uncontrollable diarrhea of any cause
  • Active keratoconjunctivitis, or corneal surgery in the past three weeks
  • Participants taking a known cytochrome P450 3A4 (CYP 3A4) inducer (e.g., phenytoin, carbamazepine, St. John's wort, and rifampin) and medications known to be inhibitors or metabolized by CYP3A4; these inhibitors include erythromycin, clarithromycin and ketoconazole, and patients taking them will be excluded since these drugs may be expected to result in altered exposure of Erlotinib
  • Hospitalization within the past 5 years for mania or for bipolar disease
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  • Participants may not be receiving any other investigational pharmaceutical agents
  • Women who are breast-feeding should not receive Erlotinib
  • Any medical or psychosocial condition that, in the opinion of the investigator, could jeopardize the subject's participation in and compliance to the study

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of California Medical Center At Irvine-Orange Campus

    Orange, California, 92868

Other trials in United States

About this study

Official title: Phase IIA Trial Testing Erlotinib as an Intervention Against Intraductal Pancreatic Mucinous Neoplasms

Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving erlotinib hydrochloride before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. This phase II trial is studying how well erlotinib hydrochloride works in treating patients with pancreatic cancer that can be removed by surgery

Read the detailed description

PRIMARY OBJECTIVES:

  1. To test the hypothesis that the activated epidermal growth factor receptor (EGFR) signal transduction biomarker Mucin 5AC (MUC5AC) protein expression within intraductal pancreatic mucinous neoplasm (IPMN) lesions will have greater than zero absolute mean decrease from baseline comparing pre and post 21-42 days of Erlotinib (erlotinib hydrochloride) administration at 100mg orally (PO) once daily (QD).

SECONDARY OBJECTIVES:

  1. To test the hypothesis that other correlative IPMN EGF inducible biomarkers will have greater than zero absolute mean decrease from baseline pre and post Erlotinib 100mg PO QD therapy.

II. Safety of Erlotinib treatment. III. To determine Erlotinib pharmacokinetic concentration in plasma and pancreatic tissue at the 100mg/day dose up to 42 days of therapy.

OUTLINE:

Patients receive erlotinib hydrochloride PO QD for 21-42 days in the absence of disease progression or unacceptable toxicity. Patients then undergo to pancreatectomy.

After completion of study treatment, patients are followed up at 4-20 weeks.

Being tested
erlotinib hydrochloride, conventional surgery, immunohistochemistry staining method, protein expression analysis, biopsy
Medical subject headings
Pancreatic Intraductal Neoplasms, Pancreatic 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 PO

  • conventional surgeryProcedure or surgery

    Also called surgery, conventional

    Undergo pancreatectomy

  • immunohistochemistry staining methodOther

    Also called immunohistochemistry

    Correlative studies

  • protein expression analysisGenetic

    Correlative studies

  • biopsyProcedure or surgery

    Also called biopsies

    Correlative studies

  • pharmacological studyOther

    Also called pharmacological studies

    Correlative studies

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00482625
Study groupRoleWhat they receive
Treatment (enzyme inhibitor therapy)ExperimentalPatients receive erlotinib hydrochloride PO QD for 21-42 days. Patients then proceed to surgery.
Receives: Drug: erlotinib hydrochloride; Procedure: conventional surgery; Other: immunohistochemistry staining method; Genetic: protein expression analysis; Procedure: biopsy; Other: pharmacological study; Other: laboratory biomarker analysis

What is being measured

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

  1. Reduction in Number of Positive IPMN Celss and Staining Intensity After Treatment

    Number of participants showed a reduction in number of positive IPMN cells and staining intensity after treatment

    Measured: Pre-treatment and post-treatment

Secondary outcomes (5)

  1. Plasma Calculated Concentration - OSI-774 (ng/mL)

    Plasma concentration levels of Erlotinib (OSI-774)

    Measured: 20 weeks

  2. Pancreas Calculated Concentration - OSI-774 (ng/g)

    Pancreatic tissue concentration levels of Erlotinib (OSI-774)

    Measured: 20 weeks

  3. Plasma Calculated Concentration - OSI-420 (ng/mL)

    Plasma concentration levels of Erlotinib (OSI-420)

    Measured: 20 weeks

  4. Pancreas Calculated Concentration - OSI-420 (ng/g)

    Pancreatic tissue concentration levels of Erlotinib (OSI-420)

    Measured: 20 weeks

  5. Number of Participants Reported at Least 1 Adverse Event With a Grade of 3 and Above

    The worst grade of pre-listed toxicity will be summarized by participant and by visit for each treatment group. Descriptive statistics (frequencies and percents) will be used to summarize data and hypotheses about group differences will be tested where appropriate.

    Measured: Up to 20 weeks

Timeline

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

  1. First posted5 Jun 2007 (estimated)
  2. Study startJun 2007
  3. Primary completionFeb 2010
  4. Study completionSep 2013

Why it stopped: The protocol has been completed prematurely (e.g., due to poor accrual, insufficient drug supply, IND closure).

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
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00482625
Sponsor's protocol ID
NCI-2009-00898
Other IDs
UCI 06-30, N01CN35160, CDR0000547235
Status last verified
Mar 2014
First submitted
4 Jun 2007
Last updated
16 Oct 2014
Data monitoring committee
Yes

Publications

  • Armstrong WB, Wan XS, Kennedy AR, Taylor TH, Meyskens FL Jr. Development of the Bowman-Birk inhibitor for oral cancer chemoprevention and analysis of Neu immunohistochemical staining intensity with Bowman-Birk inhibitor concentrate treatment. Laryngoscope. 2003 Oct;113(10):1687-702. doi: 10.1097/00005537-200310000-00007.

    PubMed 14520092

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing erlotinib hydrochloride, conventional surgery and immunohistochemistry staining method in people with Intraductal Papillary Mucinous Neoplasm of the Pancreas and Recurrent Pancreatic 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 13 inclusion and 9 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 16 Oct 2014. 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?

Yes. Results are posted in the registry (first posted 19 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Reduction in Number of Positive IPMN Celss and Staining Intensity After Treatment (time frame: Pre-treatment and post-treatment). 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 NCT00482625, which also lists 1 linked publication.

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 16 Oct 2014; AzTrials last refreshed its copy on 8 Nov 2026.

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