Status:
COMPLETED
Trial of Pemetrexed Versus Erlotinib in Pretreated Patients With Non Small Cell Lung Cancer (NSCLC)
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:
PHASE3
Brief Summary
The second-line treatment in advanced NSCLC has been currently proved effective in prolonging overall survival and improving quality of life. Both pemetrexed and erlotinib have been approved for secon...
Detailed Description
This trial will compare the efficacy of pemetrexed versus erlotinib in pretreated patients with advanced NSCLC.
Eligibility Criteria
Inclusion
- Histologically- or cytologically- confirmed Non-Small-Cell Lung Cancer adenocarcinoma
- Stage IIIB/IV
- Failure to prior chemotherapy
- Presence of two-dimensional measurable disease. The measurable disease should not have been irradiated
- Absence or irradiated and stable central nervous system metastatic disease.
- Life expectancy of more than 3 months
- Tissue sample desired for genomic study
- Age ≥ 18 years
- Performance status (WHO) \< 3
- For patients \> 65 years old: "non-frail" according to comprehensive geriatric assessment
- Adequate bone marrow function (absolute neutrophil count \> 1000/mm\^3, platelet count \> 100000/mm\^3, hemoglobin \> 9gr/mm\^3)
- Adequate liver (bilirubin \< 1.5 times upper limit of normal and SGOT/SGPT \< 2 times upper limit of normal) and renal function (creatinine \< 2mg/dl)
- Presence of a reliable care giver for patients \> 65 years old
- Informed consent.
Exclusion
- Psychiatric illness or social situation that would preclude study compliance
- Other concurrent uncontrolled illness
- Other invasive malignancy within the past 5 years except nonmelanoma skin cancer
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2010
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT00440414
Start Date
April 1 2006
End Date
April 1 2010
Last Update
August 19 2010
Active Locations (9)
Enter a location and click search to find clinical trials sorted by distance.
1
University General Hospital of Alexandroupolis, Dep of Medical Oncology
Alexandroupoli, Greece
2
401 Military Hospital, Medical Oncology Unit
Athens, Greece
3
Air Forces Military Hospital, Dep of Medical Oncology
Athens, Greece
4
IASO General Hospital of Athens, 1st Department of Medical Oncology
Athens, Greece