CClinicalTrials.gg
Sign In
CompletedNCT00440414Updated Aug 19, 2010

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

A Phase 3 interventional study of Erlotinib (Tarceva) and Pemetrexed (Alimta) in Non Small Cell Lung Cancer, sponsored by Hellenic Oncology Research Group. Completed at 9 sites in Greece. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2010-08-19.

Sponsored by Hellenic Oncology Research Group · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
320
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the detailed description

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

02

Conditions studied

  • Non Small Cell Lung Cancer

Keywords

  • Cancer
  • Non-small-cell lung cancer
  • Chemotherapy
  • Pemetrexed
  • Erlotinib
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 320 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Hellenic Oncology Research Group is the lead sponsor of 57 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
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/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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
320 participants (estimated)

Study arms

  • Experimental
    1

    Alimta

    Drug: Pemetrexed (Alimta)

  • Experimental
    2

    Tarceva

    Drug: Erlotinib (Tarceva)

Interventions

  • DrugErlotinib (Tarceva)

    Erlotinib at the dose of 150 mg orally once a day continually until progression

    Also known as: Tarceva

  • DrugPemetrexed (Alimta)

    Pemetrexed at the dose of 500mg/m2 IV infusion every 3 weeks for 6 consecutive cycles

    Also known as: Alimta

06

What researchers measure

Primary outcomes

  1. Time to Tumor Progression

    Time frame: 1 year TTP

Secondary outcomes

  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

07

Study locations

9 sites
  • 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
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 19, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00440414
Lead sponsor
Hellenic Oncology Research Group
Collaborators
University Hospital of Crete
First posted
Feb 27, 2007
Start date
Apr 2006
Primary completion
Apr 2010
Completion
Apr 2010
Last update
Aug 19, 2010

Study contacts

Lampros Vamvakas, MD
principal investigator · University Hospital of Crete
Athanasios Karampeazis, MD
principal investigator · University Hospital of Crete

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2010. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Lung Neoplasms→

Other studies from this sponsor

Hellenic Oncology Research Group

Start the discussion