Non Small Cell Lung Cancer
Conditions
Keywords
Cancer, Non-small-cell lung cancer, Chemotherapy, Pemetrexed, Erlotinib
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 second-line treatment of NSCLC . Erlotinib is a valuable option for the treatment of advanced NSCLC, especially for elderly patients, due to convenience of administration and safety profile. The role of comprehensive geriatric assessment in treatment efficacy and tolerance is an area of investigation.
Detailed description
This trial will compare the efficacy of pemetrexed versus erlotinib in pretreated patients with advanced NSCLC.
Interventions
Erlotinib at the dose of 150 mg orally once a day continually until progression
Pemetrexed at the dose of 500mg/m2 IV infusion every 3 weeks for 6 consecutive cycles
Sponsors
University Hospital of Crete
Hellenic Oncology Research Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to Tumor Progression | 1 year TTP |
Secondary
| Measure | Time frame |
|---|---|
| Overall response rate | Objective responses confirmed by CT or MRI (on 3rd and 6th cycle) |
| Overall survival between the two treatment arms | 1 year OS |
| Quality of life assessment | Assessment every two cycles |
| Toxicity profile between the two treatment arms | Toxicity assessment on each chemotherapy cycles |
Countries
Greece
Outcome results
None listed