Status:
COMPLETED
A Comparison of Two Doses of Pemetrexed in Patients Who Have Lung Cancer
Lead Sponsor:
Eli Lilly and Company
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purposes of this study are to determine: * the safety of pemetrexed and any side effects that might be associated with it * how much pemetrexed should be given to patients. It is possible that i...
Eligibility Criteria
Inclusion
- Diagnosis of locally advanced or metastatic (Stage III or IV at entry) non-small cell lung cancer (NSCLC) that is not amenable to curative therapy.
- Patients must have been previously treated with one platinum-containing chemotherapy regimen for locally advanced or metastatic disease. Patients are also eligible if they have received one platinum-based chemotherapy regimen as neoadjuvant or adjuvant chemotherapy, but must have received an additional chemotherapy regimen upon recurrence.
- No more than two prior systemic anti-cancer therapies will be allowed.
- Prior radiation therapy is allowed to less than 25% of the bone marrow. Prior radiation to the whole pelvis is not allowed. Prior radiotherapy must be completed at least 2 weeks before study enrollment, and the patient must have recovered from the acute toxic effects of the treatment prior to study enrollment.
Exclusion
- Pregnancy.
- Breast-feeding.
- Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
- Inability to interrupt aspirin, or other nonsteroidal anti-inflammatory agents for a 5-day period.
- Inability or unwillingness to take folic acid or vitamin B12 supplementation.
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
589 Patients enrolled
Trial Details
Trial ID
NCT00078260
Start Date
December 1 2003
End Date
April 1 2008
Last Update
September 12 2019
Active Locations (2)
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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.
Ankara, Turkey (Türkiye)
2
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.
Gaziantep, Turkey (Türkiye)