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

NCT00440414 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2010-08-19

No results posted yet for this 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.

Conditions

  • Non Small Cell Lung Cancer

Interventions

DRUG

Erlotinib (Tarceva)

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

DRUG

Pemetrexed (Alimta)

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

Sponsors & Collaborators

  • University Hospital of Crete

    collaborator OTHER
  • Hellenic Oncology Research Group

    lead OTHER

Principal Investigators

  • Lampros Vamvakas, MD · University Hospital of Crete

  • Athanasios Karampeazis, MD · University Hospital of Crete

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-04-30
Primary Completion
2010-04-30
Completion
2010-04-30

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00440414 on ClinicalTrials.gov