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

Sponsor
Hellenic Oncology Research Group
Study ID
NCT00440414
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Erlotinib (Tarceva) — DRUG
    Erlotinib at the dose of 150 mg orally once a day continually until progression
  • Pemetrexed (Alimta) — DRUG
    Pemetrexed at the dose of 500mg/m2 IV infusion every 3 weeks for 6 consecutive cycles

Study Details

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.

Key Dates

First listed
Feb 27, 2007
Start date
Apr 30, 2006
Status verified
Aug 2010
Primary completion
Apr 30, 2010
Completion
Apr 30, 2010

Study Design

Enrollment
320 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1
    Alimta
  • Experimental: 2
    Tarceva

Primary Outcome Measure

Time to Tumor Progression [ Time Frame: 1 year TTP ]

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