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

This study has been completed.
Sponsor:
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

February 26, 2007
August 18, 2010
April 2006
April 2010   (final data collection date for primary outcome measure)
Time to Tumor Progression [ Time Frame: 1 year TTP ] [ Designated as safety issue: No ]
Overall survival between the two treatment arms
Complete list of historical versions of study NCT00440414 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Overall response rate
  • TTP
  • quality of life assessment
  • toxicity profil between the two treatment arms
  • Correlation of clinical outcome with EGFR expression
Not Provided
Not Provided
 
Trial of Pemetrexed Versus Erlotinib in Pretreated Patients With Non Small Cell Lung Cancer (NSCLC)
A Multicenter Randomized Phase III Study of Pemetrexed Versus Erlotinib in Patients With Pretreated Advanced Non-Small-Cell Lung Cancer (NSCLC)

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.

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

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Non Small Cell Lung Cancer
  • Drug: Erlotinib (Tarceva)
    Erlotinib at the dose of 150 mg orally once a day continually until progression
    Other Name: Tarceva
  • Drug: Pemetrexed (Alimta)
    Pemetrexed at the dose of 500mg/m2 IV infusion every 3 weeks for 6 consecutive cycles
    Other Name: Alimta
  • Experimental: 1
    Alimta
    Intervention: Drug: Pemetrexed (Alimta)
  • Experimental: 2
    Tarceva
    Intervention: Drug: Erlotinib (Tarceva)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
320
April 2010
April 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Greece
 
NCT00440414
CT/06.05
No
L.Vamvakas, Hellenic Oncology Research Group
Hellenic Oncology Research Group
University Hospital of Crete
Principal Investigator: Lampros Vamvakas, MD University Hospital of Crete
Principal Investigator: Athanasios Karampeazis, MD University Hospital of Crete
Hellenic Oncology Research Group
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP