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Erlotinib as 1st Line Treatment in NSCLC Stage IIIB/IV

Primary Purpose

Non Small Cell Lung Cancer

Status
Completed
Phase
Phase 2
Locations
Greece
Study Type
Interventional
Intervention
Erlotinib
Sponsored by
Hellenic Oncology Research Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring Erlotinib, Biological therapy, Tyrosin Kinase Inhibitor therapy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • 401 Military Hospital, Medical Oncology Unit
  • Air Forces Military Hospital, Dep of Medical Oncology
  • IASO" General Hospital of Athens, 1st Dep of Medical Oncology
  • Sotiria" General Hospital, 2nd Dep of Pulmonary Diseases
  • "Diabalkaniko" Anticancer Hospital of Thessaloniki

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Tarceva

Outcomes

Primary Outcome Measures

Overall Response Rate

Secondary Outcome Measures

Overall Survival
Time to Tumor Progression
Quality of life assessment
Toxicity assesment

Full Information

First Posted
February 1, 2008
Last Updated
December 14, 2009
Sponsor
Hellenic Oncology Research Group
Collaborators
University Hospital of Crete
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1. Study Identification

Unique Protocol Identification Number
NCT00615758
Brief Title
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

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hellenic Oncology Research Group
Collaborators
University Hospital of Crete

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer
Keywords
Erlotinib, Biological therapy, Tyrosin Kinase Inhibitor therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Tarceva
Intervention Type
Drug
Intervention Name(s)
Erlotinib
Other Intervention Name(s)
Tarceva
Intervention Description
Erlotinib at the dose of 150 mg orally once a day continually until progression
Primary Outcome Measure Information:
Title
Overall Response Rate
Time Frame
Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)
Secondary Outcome Measure Information:
Title
Overall Survival
Time Frame
1-year OS
Title
Time to Tumor Progression
Time Frame
1 year TTP
Title
Quality of life assessment
Time Frame
Assessment every two cycles
Title
Toxicity assesment
Time Frame
Toxicity assessment on each cycles

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vassilis Georgoulias, MD
Organizational Affiliation
University Hospital of Crete
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Athanasios Pallis, MD
Organizational Affiliation
University Hospital of Crete
Official's Role
Principal Investigator
Facility Information:
Facility Name
401 Military Hospital, Medical Oncology Unit
City
Athens
Country
Greece
Facility Name
Air Forces Military Hospital, Dep of Medical Oncology
City
Athens
Country
Greece
Facility Name
IASO" General Hospital of Athens, 1st Dep of Medical Oncology
City
Athens
Country
Greece
Facility Name
Sotiria" General Hospital, 2nd Dep of Pulmonary Diseases
City
Athens
Country
Greece
Facility Name
"Diabalkaniko" Anticancer Hospital of Thessaloniki
City
Thessaloniki
Country
Greece

12. IPD Sharing Statement

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Erlotinib as 1st Line Treatment in NSCLC Stage IIIB/IV

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