Trial of Pemetrexed Versus Erlotinib in Pretreated Patients With Non Small Cell Lung Cancer (NSCLC)
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ClinicalTrials.gov Identifier: NCT00440414 |
Recruitment Status :
Completed
First Posted : February 27, 2007
Last Update Posted : August 19, 2010
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Non Small Cell Lung Cancer | Drug: Erlotinib (Tarceva) Drug: Pemetrexed (Alimta) | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 320 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Multicenter Randomized Phase III Study of Pemetrexed Versus Erlotinib in Patients With Pretreated Advanced Non-Small-Cell Lung Cancer (NSCLC) |
Study Start Date : | April 2006 |
Actual Primary Completion Date : | April 2010 |
Actual Study Completion Date : | April 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
Alimta
|
Drug: Pemetrexed (Alimta)
Pemetrexed at the dose of 500mg/m2 IV infusion every 3 weeks for 6 consecutive cycles
Other Name: Alimta |
Experimental: 2
Tarceva
|
Drug: Erlotinib (Tarceva)
Erlotinib at the dose of 150 mg orally once a day continually until progression
Other Name: Tarceva |
- Time to Tumor Progression [ Time Frame: 1 year TTP ]
- Overall response rate [ Time Frame: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle) ]
- Overall survival between the two treatment arms [ Time Frame: 1 year OS ]
- Quality of life assessment [ Time Frame: Assessment every two cycles ]
- Toxicity profile between the two treatment arms [ Time Frame: Toxicity assessment on each chemotherapy cycles ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00440414
Greece | |
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 |
Principal Investigator: | Lampros Vamvakas, MD | University Hospital of Crete | |
Principal Investigator: | Athanasios Karampeazis, MD | University Hospital of Crete |
Responsible Party: | L.Vamvakas, Hellenic Oncology Research Group |
ClinicalTrials.gov Identifier: | NCT00440414 History of Changes |
Other Study ID Numbers: |
CT/06.05 |
First Posted: | February 27, 2007 Key Record Dates |
Last Update Posted: | August 19, 2010 |
Last Verified: | August 2010 |
Keywords provided by Hellenic Oncology Research Group:
Cancer Non-small-cell lung cancer Chemotherapy Pemetrexed Erlotinib |
Additional relevant MeSH terms:
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic |
Bronchial Neoplasms Erlotinib Hydrochloride Pemetrexed Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |