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


Phase 3
18 Years
80 Years
Not Enrolling
Both
Non Small Cell Lung Cancer

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Trial Information

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


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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to Tumor Progression

Outcome Time Frame:

1 year TTP

Safety Issue:

No

Principal Investigator

Lampros Vamvakas, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital of Crete

Authority:

Greece: National Organization of Medicines

Study ID:

CT/06.05

NCT ID:

NCT00440414

Start Date:

April 2006

Completion Date:

April 2010

Related Keywords:

  • Non Small Cell Lung Cancer
  • Cancer
  • Non-small-cell lung cancer
  • Chemotherapy
  • Pemetrexed
  • Erlotinib
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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