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Completed

NCT Number: NCT00440414

Trial of Pemetrexed Versus Erlotinib in Pretreated Patients With 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.

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Key information

Conditions

Non Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University General Hospital of Alexandroupolis, Dep of Medical Oncology, Alexandroupoli, Greece

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Erlotinib (Tarceva)

Drug

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

Other names: Tarceva

Pemetrexed (Alimta)

Drug

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

Other names: Alimta

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

Sponsors and collaborators

Lead sponsor

Hellenic Oncology Research Group

Other

Collaborators

  • University Hospital of Crete

Registry information

Official study title

A Multicenter Randomized Phase III Study of Pemetrexed Versus Erlotinib in Patients With Pretreated Advanced Non-Small-Cell Lung Cancer (NSCLC)

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Feb 27, 2007
Registry last updated
Aug 19, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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