Status:
COMPLETED
Erlotinib as 1st Line Treatment in NSCLC Stage IIIB/IV
Lead Sponsor:
Hellenic Oncology Research Group
Collaborating Sponsors:
University Hospital of Crete
Conditions:
Non Small Cell Lung Cancer
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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 ...
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 fi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2009
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00615758
Start Date
October 1 2006
End Date
November 1 2009
Last Update
December 15 2009
Active Locations (5)
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1
401 Military Hospital, Medical Oncology Unit
Athens, Greece
2
Air Forces Military Hospital, Dep of Medical Oncology
Athens, Greece
3
IASO" General Hospital of Athens, 1st Dep of Medical Oncology
Athens, Greece
4
Sotiria" General Hospital, 2nd Dep of Pulmonary Diseases
Athens, Greece