Status:
COMPLETED
A Randomized Phase 3 Trial of Pemetrexed and Cisplatin Versus Gemcitabine and Cisplatin in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer
Lead Sponsor:
Eli Lilly and Company
Conditions:
Non Small Cell Lung Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study is a randomized Phase 3 study comparing pemetrexed and cisplatin combination to gemcitabine and cisplatin for the treatment of Non Small Cell Lung Cancer (NCSLC). Gemcitabine plus cisplatin...
Eligibility Criteria
Inclusion
- Diagnosis of NSCLC Stage IIIB not amenable to curative treatment or Stage IV.
- No prior chemotherapy for lung cancer.
- Patients must have at least one uni-dimensionally measurable lesion.
- Prior radiation therapy to less than 25% of bone marrow, whole pelvis not allowed. Radiation must be completed at least 4 weeks prior to study enrollment.
Exclusion
- Treatment with any drug within the last 30 days that has not received regulatory approval.
- Serious cardiac condition.
- Serious medical disorder in addition to NSCLC that would make it difficult for the patient to complete the study.
- Inability or unwillingness to take folic acid or Vitamin B12 supplementation.
- Presence of fluid retention that cannot be controlled by drainage.
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
1713 Patients enrolled
Trial Details
Trial ID
NCT00087711
Start Date
July 1 2004
End Date
March 1 2008
Last Update
September 12 2019
Active Locations (134)
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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) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Sacramento, California, United States
2
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Torrance, California, United States
3
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Jacksonville, Florida, United States
4
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Macon, Georgia, United States