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Pancreatic CancerPhase 2NCT01108458

A Phase 2 Study of Pertuzumab and Erlotinib for Refractory Pancreatic Adenocarcinoma

A Phase 2 study testing Pertuzumab and Erlotinib in people with Pancreatic Cancer, run by George Albert Fisher 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

A phase 2 study combining pertuzumab with erlotinib for patients with gemcitabine refractory pancreatic adenocarcinoma Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Cancer
What is being tested?
Pertuzumab and Erlotinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
1 siteUnited States
Study dates
Jul 2010to Mar 2011
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

  • 3.1 Inclusion Criteria
  • 3.1.1 Histologically-confirmed pancreatic adenocarcinoma
  • 3.1.2 One or more locally-advanced or metastatic lesions measurable in at least one dimension by modified RECIST criteria (v1.1)^13 within 4 weeks prior to entry of study
  • 3.1.3 Prior therapy (1 or more):
  • 3.1.3.1 Disease progression following therapy with gemcitabine
  • 3.1.3.2 Intolerance to gemcitabine
Show all 18Show fewer
  • 3.1.3.3 Disease recurrence within 12 months following adjuvant gemcitabine
  • 3.1.4 Age >= 18
  • 3.1.5 ECOG performance status 0-2
  • 3.1.6 Laboratory values <= 2 weeks prior to enrollment:
  • Absolute neutrophil count (ANC) >= 1.5 x 10^9/L (>= 1500/mm^3)
  • Platelets (Plt) >= 100,000/mm^3
  • Hemoglobin (Hgb) >= 9 g/dL
  • Serum creatinine <= 1.5 x ULN
  • Serum bilirubin <= 1.5 x ULN (<= 3.0 x ULN if liver metastases present)
  • Aspartate aminotransferase (AST/SGOT), alanine aminotransferase (ALT/SGPT) <= 3.0 x ULN. (<= 5.0 x ULN if liver metastases present). ERCP or percutaneous stenting may be used to normalize the liver function tests
  • 3.1.7 Echocardiogram or MUGA scan demonstrating LVEF >= 50% within 4 weeks of trial entry
  • 3.1.8 Ability to understand and the willingness to sign a written informed consent document.

Who cannot join

  • 3.2 Disease-Specific Exclusion Criteria
  • 3.2.1 Prior therapy with EGFR-targeted agents
  • 3.2.2 If history of other primary cancer, subject will be eligible only if she or he has:
  • Curatively resected non-melanomatous skin cancer
  • Curatively treated cervical carcinoma in situ
  • Other primary solid tumor curatively treated with no known active disease present and no treatment administered for the last 3 years
Show all 23Show fewer
  • 3.3 General Medical Exclusion Criteria
  • 3.3.1 Subjects known to have chronic or active hepatitis B or C infection with impaired hepatic function (ineligible if AST and ALT > 3.0 x ULN).
  • 3.3.2 History of any medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risks associated with study participation or study drug administration or may interfere with the conduct of the study or interpretation of study results
  • 3.3.3 Male subject who is not willing to use adequate contraception upon enrollment into this study and for 6 months following the last dose of study agents
  • 3.3.4 Female subject (of childbearing potential, post-menopausal for less than 6 months, not surgically sterilized, or not abstinent) who is not willing to use an oral, patch or implanted contraceptive, double-barrier birth control, or an IUD during the course of the study and for 6 months following the last dose of second-line treatment
  • 3.3.5 Female subject who is breast-feeding or who has positive serum pregnancy test 72 hours prior to enrollment
  • 3.3.6 Any of the following concurrent severe and/or uncontrolled medical conditions within 24 weeks of enrollment which could compromise participation in the study:
  • Unstable angina pectoris
  • Symptomatic congestive heart failure
  • Myocardial infarction <= 6 months prior to registration and/or randomization
  • Serious uncontrolled cardiac arrhythmia
  • Uncontrolled diabetes
  • Active or uncontrolled infection
  • Interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung
  • Chronic renal disease
  • 3.3.7 Patients unwilling to or unable to comply with the protocol
  • 3.3.8 Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech/Roche sponsored cancer study

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Stanford University School of Medicine

    Stanford, California, 94305

Other trials in United States

About this study

A phase 2 study combining pertuzumab with erlotinib for patients with gemcitabine refractory pancreatic adenocarcinoma

Read the detailed description

A single-institution, single-arm phase 2 study investigating pertuzumab and erlotinib as a palliative regimen in the treatment of locally-advanced or metastatic pancreatic adenocarcinoma.

Being tested
Pertuzumab, Erlotinib
Medical subject headings
Pancreatic Neoplasms

What participants receive

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

  • PertuzumabDrug

    Also called 2C4, Omnitarg

    iv, 840 mg, 420 mg

  • ErlotinibDrug

    Also called Erlotinib hydrochloride, Tarceva

    PO, 150 mg

Study groups in NCT01108458
Study groupRoleWhat they receive
Pertuzumab plus Erlotinib HydrochlorideExperimentalPertuzumab 840 mg intravenous (IV) single loading dose followed by 420 mg IV every 3 weeks Erlotinib hydrochloride 150 mg/day by mouth
Receives: Drug: Pertuzumab; Drug: Erlotinib

What is being measured

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

  1. Overall Response Rate by RECIST Criteria

    Measured: CT imaging every 9 weeks while on protocol

Secondary outcomes (5)

  1. Progression-free Survival (PFS)

    Disease status evaluated by computed tomography (CT) scan and progression-free survival assessed per RECIST criteria.

    Tumor response was assessed by the IRF according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeters (mm). PR was defined as greater than or equal to (≥) 30 percent (%) decrease in sum of longest diameter (LD) of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR. The percentage of participants with a confirmed objective response of CR or PR was reported.

    Measured: 9 weeks

  2. Overall Survival (OS)

    Measured: 1 year

  3. Quality of Life (QoL)

    Quality of life as assessed by EORTC QLQ-C30 questionnaire

    Measured: 3 weeks

  4. No. of Events of Drug-related Toxicity

    Number of incidences of serious and non-serious drug-related adverse events

    Measured: 3 weeks

  5. Proportion of Participants With 50% Decrease in Tumor Marker

    Change in tumor marker CA19-9, assessed as a 50% decrease from baseline

    Measured: 3 weeks

Timeline

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

  1. First posted22 Apr 2010 (estimated)
  2. Study startJul 2010
  3. Primary completionNov 2010
  4. Study completionMar 2011

Why it stopped: Extreme toxicity of Pertuzumab and Erlotinib combination

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
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01108458
Sponsor's protocol ID
IRB-18227
Other IDs
SU-03082010-5163, PANC0010
Status last verified
Jan 2017
First submitted
20 Apr 2010
Last updated
3 Mar 2017
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pertuzumab and Erlotinib in people with Pancreatic Cancer, run by George Albert Fisher 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 23 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 3 Mar 2017. 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 3 Mar 2017). 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?

Overall Response Rate by RECIST Criteria (time frame: CT imaging every 9 weeks while on protocol). 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 NCT01108458.

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 3 Mar 2017.

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