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Neuroendocrine TumorsPhase 2NCT00947167

A Phase II Study of Pertuzumab and Erlotinib for Metastatic or Unresectable Neuroendocrine Tumors

A Phase 2 study testing pertuzumab and erlotinib in people with Neuroendocrine Tumors and Carcinoid Tumors, run by Pamela L. Kunz 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

To determine objective response rates (RR) by RECIST guideline version 1.1 for all patients treated with this strategy consisting of initial therapy with pertuzumab as a single agent and then addition of erlotinib for those who have stable disease or progressive disease at three months (Simon design). Read more about this study

Who is it for?
Any age
What is being tested?
pertuzumab and erlotinib
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
1 siteUnited States
Study dates
Mar 2009to May 2010
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Subjects must be treated at Stanford University Medical Center for the entire length of study participation.
  • Patients must have histologically or cytologically confirmed well-differentiated neuroendocrine tumor. Patients must be deemed unresectable due to involvement of critical vasculature or adjacent organ invasion or have metastatic disease.
  • Patients with prior surgical resection who develop radiological or clinical evidence of metastatic cancer do not require separate histological or cytological confirmation of metastatic disease unless an interval of > 5 years has elapsed between the primary surgery and the development of metastatic disease. Clinicians should consider biopsy of lesions to establish diagnosis of metastatic disease if there is substantial clinical ambiguity regarding the nature or source of apparent metastases.
  • Prior chemotherapy will be permitted.
  • Prior or concurrent somatostatin analogue use will be permitted.
  • Patients must have a primary or metastatic lesion measurable in at least one dimension by Modified RECIST criteria (v1.1) within 4 weeks prior to entry of study.
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  • Patients must have ECOG performance status of 0-2.
  • Patients must be >= 18 years of age.
  • Laboratory values <= 2 weeks prior to randomization:
  • Absolute Neutrophil Count (ANC) >= 1.5 x 109/L (>= 1500/mm3)
  • Platelets (PLT) >= 50 x 109/L (>= 100,000/mm3) (or >= 25 x 109/L (>= 100,000/mm3) if thrombocytopenia is secondary to a non-myelosuppressive cause such as splenic sequestration).
  • 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). Note: ERCP or percutaneous stenting may be used to normalize the liver function tests.
  • Albumin >= 1.5
  • LVEF by TTE or MUGA >= 50%
  • Life expectancy >= 12 weeks
  • Ability to give written informed consent according to local guidelines

Who cannot join

  • Disease-Specific Exclusions
  • Prior full field radiotherapy <= 4 weeks or limited field radiotherapy <= 2 weeks prior to enrollment. Patients must have recovered from all therapy-related toxicities. The site of previous radiotherapy should have evidence of progressive disease if this is the only site of disease.
  • Prior biologic or immunotherapy <= 2 weeks prior to registration. Patients must have recovered from all therapy-related toxicities
  • 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
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  • Other primary solid tumor curatively treated with no known active disease present and no treatment administered for the last 3 years
  • Concurrent use of other investigational agents and patients who have received investigational drugs <= 4 weeks prior to enrollment.
  • General Medical Exclusions
  • 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).
  • 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
  • Male subject who is not willing to use adequate contraception upon enrollment into this study and for 6 months following the last dose of second-line treatment
  • 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
  • Female subject who is breast-feeding or who has positive serum pregnancy test 72 hours prior to randomization
  • Pleural effusion or ascites that causes respiratory compromise (>= CTCAE grade 2 dyspnea)
  • 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
  • Patients unwilling to or unable to comply with the protocol
  • Life expectancy of less than 12 weeks
  • Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-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

To determine objective response rates (RR) by RECIST guideline version 1.1 for all patients treated with this strategy consisting of initial therapy with pertuzumab as a single agent and then addition of erlotinib for those who have stable disease or progressive disease at three months (Simon design).

Being tested
pertuzumab, erlotinib
Medical subject headings
Neuroendocrine Tumors, Carcinoid Tumor, Adrenal Gland Neoplasms, Neuroblastoma, Multiple Endocrine Neoplasia

What participants receive

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

  • pertuzumabDrug

    Also called 2C4, Omnitarg, Genentech

    840 mg, 420 mg, iv

  • erlotinibDrug

    Also called Tarceva, Erlotinib hydrochloride

    150 mg, PO

Study groups in NCT00947167
Study groupRoleWhat they receive
Pertuzumab and ErlotinibExperimentalNot described
Receives: Drug: pertuzumab; Drug: erlotinib

What is being measured

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

  1. Response Rate (RR) for All Patients Treated With This Strategy (Simon Design)

    RECIST v1.1 used

    Measured: CT scans are done every 4 cycles (every 12 wks)

Secondary outcomes (1)

  1. Toxicities Assessed by CTCAE Grading Criteria and Assigned Attributions Accordingly

    by CTCAE

    Measured: AEs are assessed every cycle (every 3 wks)

Timeline

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

  1. First posted27 Jul 2009 (estimated)
  2. Study startMar 2009
  3. Primary completionMay 2010
  4. Study completionMay 2010

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
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00947167
Sponsor's protocol ID
NET0008
Other IDs
SU-03272009-2039, 16186, END0008
Status last verified
Jan 2017
First submitted
23 Jul 2009
Last updated
3 Mar 2017
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing pertuzumab and erlotinib in people with Neuroendocrine Tumors and Carcinoid Tumors, run by Pamela L. Kunz 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 19 inclusion and 27 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?

Response Rate (RR) for All Patients Treated With This Strategy (Simon Design) (time frame: CT scans are done every 4 cycles (every 12 wks)). 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 NCT00947167.

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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