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CancerPhase 2NCT00497224

Phase II Trial of Erlotinib in Advanced Pancreatic Cancer

A Phase 2 study testing Erlotinib in people with Cancer and Pancreas, run by University Health Network, Toronto at 5 sites in Canada.

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

This is an open-label, multi-center phase II study of erlotinib in patients with metastatic or locally advanced, unresectable pancreatic cancer who have received up to one line of gemcitabine based chemotherapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer, Pancreas
What is being tested?
Erlotinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
5 sitesCanada
Study dates
Nov 2006to Jun 2013
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 histologically or cytologically confirmed pancreatic carcinoma that is locally advanced, unresectable or metastatic.
  • 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.
  • Previous therapy:
  • Surgery: Previous surgery is permissible. Patients must be > 4 weeks from any major surgery.
  • Chemotherapy: Patients may have received up to 1 prior line of gemcitabine based systemic therapy (single agent or combination therapy) for locally advanced or metastatic disease. Prior therapy with inhibitors of angiogenesis is permitted. All toxicities must be resolved to < Grade 1 (CTCAE v 3.0) and the last dose must have been given at least 4 weeks prior to randomization.
  • Patients may also have received prior 5 FU (+/- folinic acid) or gemcitabine given concurrently with radiation as a "radiation sensitizer". All toxicities must be resolved and the last dose of chemotherapy must have been given at least 4 weeks prior to randomization.
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  • Radiation: Patients may have received prior radiation treatment for management of local disease providing that disease progression has been documented (either locally or systemically), all toxicities have resolved, and the last fraction of radiation treatment was completed at least 4 weeks prior to randomization.
  • Age >18 years. Because no dosing or adverse event data are currently available on the use of erlotinib in patients <18 years of age, children are excluded from this study but will be eligible for future pediatric single-agent trials, if applicable.
  • Life expectancy of greater than or equal to 3 months.
  • ECOG performance status <2.
  • Patients must have normal organ and marrow function as defined below:
  • Leukocytes >/= 3,000/mcL
  • Absolute neutrophil count >/= 1,000/mcL
  • Platelets >/= 100,000/mcL
  • Total bilirubin </= 1.5 UNL
  • AST(SGOT) </= 2.5 X institutional upper limit of normal
  • INR </= 1.5 unless on warfarin (see 3.1.9)
  • Creatinine within normal institutional limits OR
  • Creatinine clearance >/= 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
  • Since CYP3A4 appears to be the major enzyme responsible for the human hepatic metabolism of erlotinib in vitro, the concurrent use of inhibitors and inducers of CYP3A4 are prohibited during the study treatment period. Concurrent use of CYP3A4 substrates are allowed, however, use caution and monitor the patient for potential drug interactions.
  • There is a potential interaction between erlotinib and warfarin. Patients have experienced elevated INRs and bleeding with this combination of drugs. Patients on warfarin with PT INR >1.5 are eligible provided that all of the following criteria are met:
  • The patient is therapeutic on a stable dose of warfarin
  • The upper target for INR is no greater than 3.
  • The patient has no active bleeding or pathological condition that carries a high risk of bleeding (e.g., CT evidence of tumor invading the duodenum or known varices).
  • Note: anticoagulation with low molecular weight heparin is permitted.
  • The effects of erlotinib on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, women of child-bearing potential and men 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. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  • Ability to understand and the willingness to sign a written informed consent document.

Who cannot join

  • Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
  • Patients receiving any other investigational agents concurrently are ineligible.
  • Prior therapy with inhibitors of the EGFR (eg. cetuximab, EMD 72000, panitumumab, gefitinib, erlotinib) or multitargeted agents that inhibit EGFR (eg. ZD6474, AEE788).
  • Patients with allergies to or a history of allergic reactions attributed to any other compound of similar chemical or biologic composition to erlotinib.
  • Patients with greater than grade 1 diarrhea at baseline. Patients with pancreatic cancer often have diarrhea due to pancreatic insufficiency, so a trial of pancreatic enzymes may be warranted to reduce baseline diarrhea.
  • PT INR >1.5 unless the patient is on full-dose warfarin.
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  • Patients with any condition that impairs their ability to swallow and retain pills
  • Patients with known brain metastases will be 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, uncontrolled hypertension, 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.
  • Pregnant women are excluded from this study because erlotinib has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with erlotinib, breastfeeding should be discontinued if the mother is treated with erlotinib.
  • HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with erlotinib. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Canada5 sites

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N 4N2

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

  • British Columbia Cancer Agency

    Vancouver, British Columbia, V5Z 4E6

  • CancerCare Manitoba

    Winnipeg, Manitoba, R2H 2A6

Other trials in Canada

About this study

This is an open-label, multi-center phase II study of erlotinib in patients with metastatic or locally advanced, unresectable pancreatic cancer who have received up to one line of gemcitabine based chemotherapy.

Read the detailed description

Erlotinib in addition to gemcitabine significantly improves overall survival compared to gemcitabine alone in advanced pancreatic cancer (median overall survival 6.24 vs 5.91 months respectively). However, combined therapy has not become standard of care due to the modest absolute benefit. In NSCLC, the optimal efficacy of erlotinib is not in combination with first-line cytotoxic chemotherapy for advanced disease, but as a single agent after cytoxic chemotherapy. Preclinical and clinical data suggest that erlotinib will have activity as a single agent in advanced pancreatic cancer. The presence of an erlotinib-induced rash is associated with improved survival in phase II and III trials of diverse tumor types (reviewed by Perez-Soler et al.), and is associated with higher steady state concentrations of erlotinib.

This phase II trial aims to determine the safety and efficacy of erlotinib in patients with advanced pancreatic cancer who have previously been treated with up to one prior line of gemcitabine based chemotherapy for advanced disease. In addition, we will evaluate the feasibility and activity of dose escalation of erlotinib in patients who do not develop a rash. Clinical outcome will be correlated to EGFR status based on immunohistochemistry and gene amplification status as well as Kras mutations from archival tumor tissue.

Conditions
Cancer, Pancreas
Being tested
Erlotinib
Keywords
Pancreatic Cancer, Pancreatic Carcinoma, Pancreas, Adenocarcinoma, Erlotinib, Tarceva, OSI-774, Phase II
Medical subject headings
Neoplasms, Pancreatic Neoplasms, Adenocarcinoma

What participants receive

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

  • ErlotinibDrug

    Also called TARCEVA, OSI-774

    Erlotinib starting at 150 mg PO (by mouth) daily. Dose may increase or decrease by the study doctor as per protocol (study plan).

Study groups in NCT00497224
Study groupRoleWhat they receive
ErlotinibExperimentalEligible patients will receive erlotinib 150mg PO daily, with dose escalation occurring as tolerated.
Receives: Drug: Erlotinib

What is being measured

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

  1. Objective Response Rate

    Measured by the rate of disease control (objective response plus prolonged stable disease), in patients with unresectable, locally advanced or metastatic pancreatic adenocarcinoma.

    Measured: Clinically assessed every cycle (month) and radiologically assessed every 2 cycles (2 months) with CT scan

Secondary outcomes (2)

  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability of Erlotinib]

    Incidence of adverse events related to treatment, through monthly SAE analysis.

    Measured: Assessed every cycle (month)

  2. Tolerability of Erlotinib Dose Escalation

    Assessment erlotinib dose escalation efficacy through analysis of patients who do not develop a rash by cycle 1, day 15.

    Measured: assessed cycle 1, day 28, then every cycle (month)

Timeline

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

  1. First posted6 Jul 2007 (estimated)
  2. Study startNov 2006
  3. Primary completionDec 2008
  4. Study completionJun 2013

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
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00497224
Sponsor's protocol ID
OSI-Tar-725
Status last verified
May 2019
First submitted
4 Jul 2007
Last updated
30 May 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • Renouf DJ, Tang PA, Hedley D, Chen E, Kamel-Reid S, Tsao MS, Tran-Thanh D, Gill S, Dhani N, Au HJ, Wang L, Moore MJ. A phase II study of erlotinib in gemcitabine refractory advanced pancreatic cancer. Eur J Cancer. 2014 Jul;50(11):1909-15. doi: 10.1016/j.ejca.2014.04.008. Epub 2014 May 21.

    PubMed 24857345

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Erlotinib in people with Cancer and Pancreas, run by University Health Network, Toronto at 5 sites in Canada.

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 27 inclusion and 11 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 30 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Canada. 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?

Objective Response Rate (time frame: Clinically assessed every cycle (month) and radiologically assessed every 2 cycles (2 months) with CT scan). 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 NCT00497224, 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 30 May 2019.

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