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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
Sponsor:
Collaborator:
University Hospital of Crete
Information provided by:
Hellenic Oncology Research Group

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Drug: Erlotinib (Tarceva) Drug: Pemetrexed (Alimta) Phase 3

Detailed Description:
This trial will compare the efficacy of pemetrexed versus erlotinib in pretreated patients with advanced NSCLC.

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arms and Interventions
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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


Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Time to Tumor Progression [ Time Frame: 1 year TTP ]

Secondary Outcome Measures :
  1. Overall response rate [ Time Frame: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle) ]
  2. Overall survival between the two treatment arms [ Time Frame: 1 year OS ]
  3. Quality of life assessment [ Time Frame: Assessment every two cycles ]
  4. Toxicity profile between the two treatment arms [ Time Frame: Toxicity assessment on each chemotherapy cycles ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

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


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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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