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Trial of Pemetrexed Versus Erlotinib in Pretreated Patients With Non Small Cell Lung Cancer (NSCLC)

Sponsor
Hellenic Oncology Research Group (Other)
Overall Status
Completed
CT.gov ID
NCT00440414
Collaborator
University Hospital of Crete (Other)
320
Enrollment
9
Locations
2
Arms
48
Duration (Months)
35.6
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

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
  • 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

Study Type:
Interventional
Anticipated 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 :
Apr 1, 2006
Actual Primary Completion Date :
Apr 1, 2010
Actual Study Completion Date :
Apr 1, 2010

Arms and Interventions

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 Names:
  • Alimta

    		•
    Experimental: 2

    Tarceva

    Drug: Erlotinib (Tarceva)
    Erlotinib at the dose of 150 mg orally once a day continually until progression
    Other Names:
  • Tarceva

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Time to Tumor Progression [1 year TTP]

    Secondary Outcome Measures

    1. Overall response rate [Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)]

    2. Overall survival between the two treatment arms [1 year OS]

    3. Quality of life assessment [Assessment every two cycles]

    4. Toxicity profile between the two treatment arms [Toxicity assessment on each chemotherapy cycles]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    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/mm3, platelet count > 100000/mm3, 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

    Locations

    Site City State Country Postal Code
    1 University General Hospital of Alexandroupolis, Dep of Medical Oncology Alexandroupolis Greece
    2 401 Military Hospital, Medical Oncology Unit Athens Greece
    3 Air Forces Military Hospital, Dep of Medical Oncology Athens Greece
    4 IASO General Hospital of Athens, 1st Department of Medical Oncology Athens Greece
    5 Laikon General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine Athens Greece
    6 Sismanogleio General Hospital, 1st, 2nd Department of Pulmonary Diseases Athens Greece
    7 Sotiria General Hospital, 1st, 3rd, 8th Dep of Pulmonary Diseases Athens Greece
    8 Metaxa's Anticancer Hospital of Piraeus,1st Dep of Medical Oncology Piraeus Greece
    9 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00440414
    Other Study ID Numbers:
    • CT/06.05
    First Posted:
    Feb 27, 2007
    Last Update Posted:
    Aug 19, 2010
    Last Verified:
    Aug 1, 2010
    Keywords provided by , ,
    Cancer
    Non-small-cell lung cancer
    Chemotherapy
    Pemetrexed
    Erlotinib
    Additional relevant MeSH terms:
    Lung Neoplasms
    Carcinoma, Non-Small-Cell Lung
    Pemetrexed
    Erlotinib Hydrochloride

    Study Results

    No Results Posted as of Aug 19, 2010