Clinical trial NCT00615758: Erlotinib as 1st Line Treatment in NSCLC Stage IIIB/IV
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non Small Cell Lung Cancer
Keywords: Erlotinib
Biological therapy
Tyrosin Kinase Inhibitor therapy
Lead sponsor: Hellenic Oncology Research Group
Sponsor class: OTHER
Collaborators: name: University Hospital of Crete
First posted: 2008-02-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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

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 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

Primary outcomes:
measure: Overall Response Rate
timeFrame: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)
Secondary outcomes:
measure: Overall Survival
timeFrame: 1-year OS
measure: Time to Tumor Progression
timeFrame: 1 year TTP
measure: Quality of life assessment
timeFrame: Assessment every two cycles
measure: Toxicity assesment
timeFrame: Toxicity assessment on each cycles
Other outcomes:
Locations:
city: Athens
country: Greece
facility: 401 Military Hospital, Medical Oncology Unit
city: Athens
country: Greece
facility: Air Forces Military Hospital, Dep of Medical Oncology
city: Athens
country: Greece
facility: IASO" General Hospital of Athens, 1st Dep of Medical Oncology
city: Athens
country: Greece
facility: Sotiria" General Hospital, 2nd Dep of Pulmonary Diseases
city: Thessaloniki
country: Greece
facility: "Diabalkaniko" Anticancer Hospital of Thessaloniki
Study officials:
affiliation: University Hospital of Crete
name: Vassilis Georgoulias, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of Crete
name: Athanasios Pallis, MD
role: PRINCIPAL_INVESTIGATOR
References: