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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1
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