Trastuzumab Therapy in Non-Small Cell Lung Cancer Patients

This study has been terminated.
(Insufficient accrual)
Sponsor:
Information provided by (Responsible Party):
Armando Santoro, MD, Istituto Clinico Humanitas
ClinicalTrials.gov Identifier:
NCT00758134
First received: September 22, 2008
Last updated: May 27, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
NON-SMALL CELL LUNG CANCER
Drug: Trastuzumab (Herceptin)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Istituto Clinico Humanitas:

Primary Outcome Measures:
  • Response rate [ Time Frame: every two months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to disease progression, overall survival, safety and assessment of biomarkers potentially implicated in trastuzumab sensitivity/resistance [ Time Frame: every two months ] [ Designated as safety issue: Yes ]

Enrollment: 9
Study Start Date: July 2008
Study Completion Date: December 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Trastuzumab 6 mg/Kg
Drug: Trastuzumab (Herceptin)
Trastuzumab 6 mg/Kg every 3 weeks i.v. (loading dose 8 mg/Kg i.v.)
Other Name: Herceptin

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • • 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
    • 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.

Exclusion Criteria:

  • • 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%
    • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00758134

Locations
Italy
Istituto Clinico Humanitas
Rozzano, Milano, Italy, 20089
Sponsors and Collaborators
Armando Santoro, MD
Investigators
Principal Investigator: Armando Santoro, MD Istituto Clinico Humanitas
  More Information

No publications provided

Responsible Party: Armando Santoro, MD, MD, Istituto Clinico Humanitas
ClinicalTrials.gov Identifier: NCT00758134     History of Changes
Other Study ID Numbers: ONC-2007-001, 2007-003709-29
Study First Received: September 22, 2008
Last Updated: May 27, 2013
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Trastuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014