Status:
COMPLETED
A Single Arm Phase 2 Study of Pemetrexed as 2nd-Line Treatment of Advanced Non-Small Cell Lung Cancer
Lead Sponsor:
Eli Lilly and Company
Conditions:
Carcinoma, Non-Small Cell Lung
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
In previous phase 2 studies, pemetrexed has shown antitumor activity in advanced non-small cell lung cancer as a single agent as well as in combination with cisplatin. Since the introduction of vitami...
Eligibility Criteria
Inclusion
- diagnosis of NSCLC
- Locally advanced or metastatic disease (Stage IIIB or IV).
- Patients must have previously received one chemotherapy regimen for palliative therapy of locally advanced or metastatic disease.
- Disease status must be that of measurable disease as defined by RECIST criteria
- Performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) Scale; and adequate organ function.
Exclusion
- Known or suspected brain metastasis, or Second primary malignancy that is clinically detectable at the time of consideration for study enrollment
- Concurrent administration of any other tumor therapy.
- History of significant neurological or mental disorder, including seizures or dementia; or any other serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study
- Inability to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) 2 days before, the day of, and 2 days after the dose of pemetrexed.
- Inability or unwillingness to take folic acid, vitamin B12 supplementation, or dexamethasone
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
End Date :
October 1 2005
Estimated Enrollment :
186 Patients enrolled
Trial Details
Trial ID
NCT00190840
Start Date
September 1 2003
End Date
October 1 2005
Last Update
January 26 2007
Active Locations (20)
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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.
Wollongong, New South Wales, Australia, 2500
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.
Chermside, Queensland, Australia, 4032
3
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.
Ashford, South Australia, Australia, 5035
4
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.
Fitzroy, Victoria, Australia, 3065