NCT00615758

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2006

Typical duration for phase_2

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

February 1, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 14, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

December 15, 2009

Status Verified

December 1, 2009

Enrollment Period

3.1 years

First QC Date

February 1, 2008

Last Update Submit

December 14, 2009

Conditions

Non Small Cell Lung Cancer

Keywords

ErlotinibBiological therapyTyrosin Kinase Inhibitor therapy

Outcome Measures

Primary Outcomes (1)

  • Overall Response Rate

    Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)

Secondary Outcomes (4)

  • Overall Survival

    1-year OS

  • Time to Tumor Progression

    1 year TTP

  • Quality of life assessment

    Assessment every two cycles

  • Toxicity assesment

    Toxicity assessment on each cycles

Study Arms (1)

1

EXPERIMENTAL

Tarceva

Drug: Erlotinib

Interventions

ErlotinibDRUG

Erlotinib at the dose of 150 mg orally once a day continually until progression

Also known as: Tarceva
1

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

401 Military Hospital, Medical Oncology Unit

Athens, Greece

Location

Air Forces Military Hospital, Dep of Medical Oncology

Athens, Greece

Location

IASO" General Hospital of Athens, 1st Dep of Medical Oncology

Athens, Greece

Location

Sotiria" General Hospital, 2nd Dep of Pulmonary Diseases

Athens, Greece

Location

"Diabalkaniko" Anticancer Hospital of Thessaloniki

Thessaloniki, Greece

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Vassilis Georgoulias, MD

    University Hospital of Crete

    PRINCIPAL INVESTIGATOR

  • Athanasios Pallis, MD

    University Hospital of Crete

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 1, 2008

First Posted

February 14, 2008

Study Start

October 1, 2006

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

December 15, 2009

Record last verified: 2009-12

Locations

GR(5)