Trial of Pemetrexed Versus Erlotinib in Pretreated Patients With Non Small Cell Lung Cancer (NSCLC)
NCT00440414 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 320
Last updated 2010-08-19
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.
Conditions
- Non Small Cell Lung Cancer
Interventions
- DRUG
-
Erlotinib (Tarceva)
Erlotinib at the dose of 150 mg orally once a day continually until progression
- DRUG
-
Pemetrexed (Alimta)
Pemetrexed at the dose of 500mg/m2 IV infusion every 3 weeks for 6 consecutive cycles
Sponsors & Collaborators
-
University Hospital of Crete
collaborator OTHER -
Hellenic Oncology Research Group
lead OTHER
Principal Investigators
-
Lampros Vamvakas, MD · University Hospital of Crete
-
Athanasios Karampeazis, MD · University Hospital of Crete
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-04-30
- Primary Completion
- 2010-04-30
- Completion
- 2010-04-30
Countries
- Greece
Study Locations
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