Status:

COMPLETED

Dosage Schedule Study of Pemetrexed Monochemotherapy for Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

Lead Sponsor:

Eli Lilly and Company

Conditions:

Non Small Cell Lung Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

Patients affected by non-small cell lung cancer (NSCLC) will be treated in pemetrexed monochemotherapy regimen for a maximum of 8 cycles. Pemetrexed is an enhancer of some biomolecules involved in the...

Eligibility Criteria

Inclusion

  • Inclusion Criteria
  • Histologically or cytologically proven IIIB and IV NSCLC.
  • No symptomatic uncontrolled brain metastasis
  • Not suitable for platinum containing regimens if chemo-naive
  • Performance status less than or equal to 2 on the Eastern Cooperative Oncology Group (ECOG) Scale.
  • Creatinine Clearance (CrCl) greater than or equal to 45 milliliters per min (mL/min)
  • Exclusion Criteria
  • Prior radiation to greater than 25% of bone marrow
  • Inability to interrupt Aspirin at doses of greater than 1.3 grams/day or non-steroidal anti-inflammatory agents for a 5-day period.
  • Presence of clinically relevant third-space fluid collections not controllable.
  • Significant cardiac disease

Exclusion

    Key Trial Info

    Start Date :

    September 1 2006

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    September 1 2008

    Estimated Enrollment :

    19 Patients enrolled

    Trial Details

    Trial ID

    NCT00370292

    Start Date

    September 1 2006

    End Date

    September 1 2008

    Last Update

    October 20 2009

    Active Locations (1)

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    For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Milan, Italy