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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00440414
Recruitment Status : Completed
First Posted : February 27, 2007
Last Update Posted : August 19, 2010
University Hospital of Crete
Information provided by:
Hellenic Oncology Research Group

February 26, 2007
February 27, 2007
August 19, 2010
April 2006
April 2010   (Final data collection date for primary outcome measure)
Time to Tumor Progression [ Time Frame: 1 year TTP ]
Overall survival between the two treatment arms
Complete list of historical versions of study NCT00440414 on Archive Site
  • 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 ]
  • 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.
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
    Intervention: Drug: Pemetrexed (Alimta)
  • Experimental: 2
    Intervention: Drug: Erlotinib (Tarceva)
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
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