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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00440414 |
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Date of registration:
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26/02/2007 |
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Primary sponsor: |
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Public title:
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Trial of Pemetrexed Versus Erlotinib in Pretreated Patients With Non Small Cell Lung Cancer (NSCLC)
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Scientific title:
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A Multicenter Randomized Phase III Study of Pemetrexed Versus Erlotinib in Patients With Pretreated Advanced Non-Small-Cell Lung Cancer (NSCLC) |
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Date of first enrolment:
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April 2006 |
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Target sample size:
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320 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00440414 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Greece
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Contacts
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Name:
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Athanasios Karampeazis, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital of Crete |
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Name:
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Lampros Vamvakas, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital of Crete |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Non Small Cell Lung Cancer
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Intervention(s)
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Drug: Erlotinib (Tarceva)
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Drug: Pemetrexed (Alimta)
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Primary Outcome(s)
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Time to Tumor Progression
[Time Frame: 1 year TTP]
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Secondary Outcome(s)
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Overall response rate
[Time Frame: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)]
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Overall survival between the two treatment arms
[Time Frame: 1 year OS]
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Quality of life assessment
[Time Frame: Assessment every two cycles]
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Toxicity profile between the two treatment arms
[Time Frame: Toxicity assessment on each chemotherapy cycles]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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