AzTrials
AzTrials

NON-SMALL CELL LUNG CANCERPhase 2NCT00758134

Trastuzumab Therapy in Non-Small Cell Lung Cancer Patients

A Phase 2 study testing Trastuzumab (Herceptin) in people with NON-SMALL CELL LUNG CANCER, run by Armando Santoro, MD at 1 site in Italy.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

This is a prospective study assessing efficacy of trastuzumab therapy in pretreated NSCLC patients. Patients with locally advanced or metastatic NSCLC, HER2 FISH positive and/or with HER2 gene mutation, pretreated with at least one previous chemotherapy line will be considered eligible for the trial. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
NON-SMALL CELL LUNG CANCER
What is being tested?
Trastuzumab (Herceptin)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteItaly
Study dates
Jul 2008to Dec 2010
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 confirmed diagnosis of NSCLC. Availability of tumor tissue for HER2 FISH analysis and/or HER2 gene mutation analysis is mandatory
  • Stage IIIB (with effusion) or stage IV or disease relapsed after surgery or radiotherapy and in any case not suitable for radiotherapy or surgery with curative intent
  • HER2 FISH positive defined as high polysomy or gene amplification, or presence of HER2 gene mutation in exon 20
  • At least one measurable lesion
  • Patients pretreated with at least one chemotherapy regimen. Previous therapy with erlotinib or other tyrosine kinase inhibitors is allowed.
  • Patients compliance to trial procedures
Show all 14Show fewer
  • Age ≥ 18 years
  • Written informed consent
  • Adequate BM function (ANC ≥1.5x109/L, Platelets ≥100x109/L, HgB >9 g/dl)
  • Adequate liver function (bilirubin <G2, transaminases no more than 3xULN/<5xULN in present of liver metastases).
  • Normal level of alkaline phosphatase and creatinine
  • If female: childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of approved contraceptive method [intrauterine contraceptive device (IUD), birth control pills, or barrier device] during and for three months after trial.
  • ECOG performance status 0-1 and life expectancy of at least 3 months
  • Have recovered from the acute, reversible effects of prior surgery or radiotherapy. This means that at least 3 weeks should have elapsed since prior radiotherapy.

Who cannot join

  • • HER2 FISH negative tumor and no evidence of HER2 gene mutation in exon 20
  • Concomitant radiotherapy
  • Untreated brain metastases or leptomeningeal disease involvement.
  • All disease sites previously included in radiotherapy fields. If all sites were included in radiotherapy fields patient is eligible only if there is evidence of progressive disease after completion of radiotherapy.
  • No measurable lesion
  • Left ventricular ejection fraction (FEV) <50%
Show all 11Show fewer
  • Diagnosis of any other malignancy during the last 5 years, except for in situ carcinoma of cervix uteri and squamous cell carcinoma of the skin
  • Any previous HER2 blocking therapy. Previous therapy with anti EGFR agents is allowed
  • Pregnancy or lactating
  • Other serious illness or medical condition including: Congestive heart failure (NYHA class II, III, IV) or history of documented congestive heart failure, unstable angina pectoris, myocardial infarction in the last 12 months, poorly controlled hypertension (systolic >180 mmHg or diastolic >100 mmHg), clinically significant valvular heart disease, or high-risk uncontrolled arrhythmias. Patients with dyspnoea at rest due to malignant or other disease (e.g. pulmonary metastases with lymphangitis) or who require supportive oxygen therapy. Active serious uncontrolled infections. Poorly controlled diabetes mellitus
  • Treatment with any investigational drug within 30 days before the beginning of treatment with study drug.

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Istituto Clinico Humanitas

    Rozzano, Milano, 20089

Other trials in Italy

About this study

Official title: Prospective Phase II Trial Evaluating Efficacy of Trastuzumab Therapy in HER2 FISH Positive and/or HER2 Mutation Positive, Pretreated, Non-Small Cell Lung Cancer Patients (MO20509)

This is a prospective study assessing efficacy of trastuzumab therapy in pretreated NSCLC patients. Patients with locally advanced or metastatic NSCLC, HER2 FISH positive and/or with HER2 gene mutation, pretreated with at least one previous chemotherapy line will be considered eligible for the trial. After evaluation of inclusion and exclusion criteria, and after signature of informed consensus form, all eligible patients will receive trastuzumab 6 mg/kg every 3 weeks (8 mg/kg loading dose) until disease progression, unacceptable toxicity or patient refusal.

Being tested
Trastuzumab (Herceptin)
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • Trastuzumab (Herceptin)Drug

    Also called Herceptin

    Trastuzumab 6 mg/Kg every 3 weeks i.v. (loading dose 8 mg/Kg i.v.)

Study groups in NCT00758134
Study groupRoleWhat they receive
AExperimentalTrastuzumab 6 mg/Kg
Receives: Drug: Trastuzumab (Herceptin)

What is being measured

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

  1. Response rate

    Measured: every two months

Secondary outcomes (1)

  1. Time to disease progression, overall survival, safety and assessment of biomarkers potentially implicated in trastuzumab sensitivity/resistance

    Measured: every two months

Timeline

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

  1. First posted23 Sep 2008 (estimated)
  2. Study startJul 2008
  3. Primary completionJun 2010
  4. Study completionDec 2010

Why it stopped: Insufficient accrual

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
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00758134
Sponsor's protocol ID
ONC-2007-001
Other IDs
2007-003709-29
Status last verified
May 2013
First submitted
22 Sep 2008
Last updated
29 May 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Trastuzumab (Herceptin) in people with NON-SMALL CELL LUNG CANCER, run by Armando Santoro, MD at 1 site in Italy.

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 14 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: stopped early, as of the sponsor's last update on 29 May 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 Italy. 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 was stopped early (reason given: Insufficient accrual). Results are not available in the source record.

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 (time frame: every two months). 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 NCT00758134.

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 29 May 2013.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in