Trial of Pemetrexed Versus Erlotinib in Pretreated Patients With Non Small Cell Lung Cancer (NSCLC)
This study has been completed.
Sponsor:
Hellenic Oncology Research Group
Collaborator:
University Hospital of Crete
Information provided by:
Hellenic Oncology Research Group
ClinicalTrials.gov Identifier:
NCT00440414
First received: February 26, 2007
Last updated: August 18, 2010
Last verified: August 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Non Small Cell Lung Cancer |
Drug: Erlotinib (Tarceva) Drug: Pemetrexed (Alimta) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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) |
Resource links provided by NLM:
Further study details as provided by Hellenic Oncology Research Group:
Primary Outcome Measures:
- Time to Tumor Progression [ Time Frame: 1 year TTP ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Overall response rate [ Time Frame: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle) ] [ Designated as safety issue: No ]
- Overall survival between the two treatment arms [ Time Frame: 1 year OS ] [ Designated as safety issue: No ]
- Quality of life assessment [ Time Frame: Assessment every two cycles ] [ Designated as safety issue: No ]
- Toxicity profile between the two treatment arms [ Time Frame: Toxicity assessment on each chemotherapy cycles ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 320 |
| Study Start Date: | April 2006 |
| Study Completion Date: | April 2010 |
| Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Detailed Description:
This trial will compare the efficacy of pemetrexed versus erlotinib in pretreated patients with advanced NSCLC.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00440414
Please refer to this study by its ClinicalTrials.gov identifier: NCT00440414
Locations
| 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 | |
Sponsors and Collaborators
Hellenic Oncology Research Group
University Hospital of Crete
Investigators
| Principal Investigator: | Lampros Vamvakas, MD | University Hospital of Crete |
| Principal Investigator: | Athanasios Karampeazis, MD | University Hospital of Crete |
More Information
| Responsible Party: | L.Vamvakas, Hellenic Oncology Research Group |
| ClinicalTrials.gov Identifier: | NCT00440414 History of Changes |
| Other Study ID Numbers: | CT/06.05 |
| Study First Received: | February 26, 2007 |
| Last Updated: | August 18, 2010 |
| Health Authority: | Greece: National Organization of Medicines |
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 |
ClinicalTrials.gov processed this record on September 23, 2016