Erlotinib as 1st Line Treatment in NSCLC Stage IIIB/IV - Full Text View

Sponsors and Collaborators:	Hellenic Oncology Research Group University Hospital of Crete
Information provided by:	Hellenic Oncology Research Group
ClinicalTrials.gov Identifier:	NCT00615758

Purpose

To evaluate the efficacy and toxicity of erlotinib as first line treatment in patients with locally advanced/metastatic (stages IIIB/IV) NSCLC, with clinical predictors of response to tyrosine kinase inhibitors (erlotinib, gefitinib), such as female gender, never-smoking status and adenocarcinoma histology. Furthermore, erlotinib-sensitivity will be correlated with the presence of EGFR mutations in exons 18, 19 and 21, in this population

Condition	Intervention	Phase
Non Small Cell Lung Cancer	Drug: Erlotinib	Phase II

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Erlotinib Erlotinib hydrochloride Epidermal Growth Factor Tyrosine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study
Official Title:	ERLOTINIB, A TYROSINE KINASE INHIBITOR OF EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) AS FIRST LINE TREATMENT, IN PATIENTS WITH LOCALLY ADVANCED/METASTATIC NON SMALL CELL LUNG CANCER (NSCLC). A PHASE II STUDY

Further study details as provided by Hellenic Oncology Research Group:

Primary Outcome Measures:

Overall Response Rate [ Time Frame: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall Survival [ Time Frame: 1-year OS ] [ Designated as safety issue: No ]
Time to Tumor Progression [ Time Frame: 1 year TTP ] [ Designated as safety issue: No ]
Quality of life assessment [ Time Frame: Assessment every two cycles ] [ Designated as safety issue: No ]
Toxicity assesment [ Time Frame: Toxicity assessment on each cycles ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	50
Study Start Date:	October 2006
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Tarceva	Drug: Erlotinib Erlotinib at the dose of 150 mg orally once a day continually until progression

Detailed Description:

A randomized, placebo-controlled phase III trial of erlotinib versus placebo, with more than 700 patients demonstrated that therapy with this tyrosine kinase inhibitor (TKI) prolongs survival after first or second line therapy in patients with advanced NSCLC. Statistically significant and clinically relevant differences were observed for overall and progression free survival in favour of erlotinib. Moreover, several clinical factors had been correlated with response to gefitinib or erlotinib, including never smoking status, female gender, Asian ethnicity and adenocarcinoma histology (especially bronchioalveolar carcinoma).

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically or cytologically confirmed, unresectable locally advanced (stage IIIB with pleural effusion) and/or metastatic (stage IV) NSCLC
No previous therapy for advanced/metastatic NSCLC is allowed
age >18 years
bidimensionally measurable disease
non-smokers (or ex-smokers with less than 5 pack-years smoking history)
adenocarcinoma histology
performance status (WHO) 0-3
adequate liver (serum bilirubin <1.5 times the upper normal limit (UNL); AST and ALT <2.5 times the UNL in the absence of demonstrable liver metastases, or <5 times the UNL in the presence of liver metastases); adequate renal function (serum creatinine <1.5 times the UNL); and bone marrow (neutrophils ≥ 1.5x 109 /L, and platelets ≥ 100x 109 /L) function
previous radiotherapy, either in the adjuvant setting or for the treatment of metastatic disease is allowed provided that the measurable lesions are outside the radiation fields
patient able to take oral medication
tissue sample for tumour mutational analysis is required

Exclusion Criteria:

serious chronic skin conditions (e.g. psoriasis, eczema) that would preclude study participation
active infection
history of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
malnutrition (loss of ≥ 20% of the original body weight)
performance status: 4
psychiatric illness or social situation that would preclude study compliance
pregnant or lactating women

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00615758

Contacts

Contact: Dora Hatzidaki	+302810392570	dorachat@med.uoc.gr
Contact: Sofia Mavraki	+302810392987	maurakh@gmail.com

Locations

Greece
IASO" General Hospital of Athens, 1st Dep of Medical Oncology	Recruiting
Athens, Greece
Contact: Nikoleta Karkatzou +302106442666 secretary@horg.gr
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
Principal Investigator: Stelios Giassas, MD
Sotiria" General Hospital, 2nd Dep of Pulmonary Diseases	Recruiting
Athens, Greece
Contact: Nikoleta Karkatzou, MD +302106448666 secretary@horg.gr
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
Principal Investigator: Blastos, MD
"Diabalkaniko" Anticancer Hospital of Thessaloniki	Recruiting
Thessaloniki, Greece
Contact: Nikoleta Karkatzou, MD +302106448666 secretary@horg.gr
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
Principal Investigator: Touroutoglou, MD
401 Military Hospital, Medical Oncology Unit	Recruiting
Athens, Greece
Contact: Nikoleta Karkatzou, MD +302106457968 secretary@horg.gr
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
Principal Investigator: Charalambos Christophillakis, MD
Air Forces Military Hospital, Dep of Medical Oncology	Recruiting
Athens, Greece
Contact: Nikoleta Karkatzou, MD +302106448666 secretary@horg.gr
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
Principal Investigator: Nikos Kentepozidis, MD

Sponsors and Collaborators

Hellenic Oncology Research Group

University Hospital of Crete

Investigators

Principal Investigator:	Vassilis Georgoulias, MD	University Hospital of Crete
Principal Investigator:	Athanasios Pallis, MD	University Hospital of Crete

More Information

Responsible Party:	Hellenic Oncology Research Group ( V.Georgoulias )
Study ID Numbers:	CT/06.03
Study First Received:	February 1, 2008
Last Updated:	September 8, 2008
ClinicalTrials.gov Identifier:	NCT00615758
Health Authority:	Greece: National Organization of Medicines

Keywords provided by Hellenic Oncology Research Group:

Erlotinib
Biological therapy
Tyrosin Kinase Inhibitor therapy

Study placed in the following topic categories:

Erlotinib
Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms

Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009