Trial of Pemetrexed Versus Erlotinib in Pretreated Patients With Non Small Cell Lung Cancer (NSCLC)
Information source: Hellenic Oncology Research Group
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Non Small Cell Lung Cancer
Intervention: Erlotinib (Tarceva) (Drug); Pemetrexed (Alimta) (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Hellenic Oncology Research Group Official(s) and/or principal investigator(s): Lampros Vamvakas, MD, Principal Investigator, Affiliation: University Hospital of Crete Athanasios Karampeazis, MD, Principal Investigator, Affiliation: University Hospital of Crete
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.
Clinical Details
Official title: A Multicenter Randomized Phase III Study of Pemetrexed Versus Erlotinib in Patients With Pretreated Advanced Non-Small-Cell Lung Cancer (NSCLC)
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Time to Tumor Progression
Secondary outcome: Overall response rateOverall survival between the two treatment arms Quality of life assessment Toxicity profile between the two treatment arms
Detailed description:
This trial will compare the efficacy of pemetrexed versus erlotinib in pretreated patients
with advanced NSCLC.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
University General Hospital of Alexandroupolis, Dep of Medical Oncology, Alexandroupolis, Greece
401 Military Hospital, Medical Oncology Unit, Athens, Greece
Air Forces Military Hospital, Dep of Medical Oncology, Athens, Greece
IASO General Hospital of Athens, 1st Department of Medical Oncology, Athens, Greece
Laikon General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine, Athens, Greece
Sismanogleio General Hospital, 1st, 2nd Department of Pulmonary Diseases, Athens, Greece
Sotiria General Hospital, 1st, 3rd, 8th Dep of Pulmonary Diseases, Athens, Greece
Metaxa's Anticancer Hospital of Piraeus,1st Dep of Medical Oncology, Piraeus, Greece
Theagenion Anticancer Hospital of Thessaloniki, Thessaloniki, Greece
Additional Information
Starting date: April 2006
Last updated: August 18, 2010
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