Status:
COMPLETED
A Study of Thymidylate Synthase Expression in Patients With Non-Small Cell Lung Cancer
Lead Sponsor:
Eli Lilly and Company
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Thymidylate synthase (TS) is a substance the body produces naturally. The purpose of this research is to determine if there is a link between TS production and how well patients respond to treatment o...
Detailed Description
All patients on this study will receive 4 intravenous injections of the chemotherapy drugs pemetrexed and cisplatin (with each injection approximately 3 weeks apart). Patients who complete 4 such inje...
Eligibility Criteria
Inclusion
- Patients must have Stage 3B or 4 Non-Small Cell Lung Cancer of the non- squamous type
- Patients must at least be able to be physically mobile, take care of yourself and be able to perform light activities such as light housework or office work
- Patients must not have had previous chemotherapy treatment for lung cancer
- Patients must not have had radiotherapy in the last 30 days
- Patients must have measureable tumor lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines or disease that can be evaluated on computed tomography (CT) scan
- Patients' test results assessing the function of their blood forming tissue, kidneys, liver and lungs are satisfactory
- Women must be sterile, postmenopausal or on contraception and men must be sterile or on contraception
Exclusion
- Patients cannot have received other investigational drugs within the last 30 days
- Patients cannot have any serious, uncontrolled medical condition that might compromise their ability to take part in the study safely
- Patients cannot have a current second primary malignant tumor
- Patients cannot be having current treatment with any other anti-tumor therapy
- Patients cannot have had a yellow fever vaccination within 30 days of enrolment
- Patients who are unable to take vitamins (including injections of vitamin B12) or oral cortisone medication
- Patients who are unable to stop taking more than 1.3 grams of aspirin on a daily basis or non-steroidal anti-inflammatory agents
- Patients who are pregnant or breastfeeding
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00887549
Start Date
April 1 2009
End Date
June 1 2011
Last Update
June 19 2012
Active Locations (14)
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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.
Dublin, Ireland
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.
Derby, Derbyshire, United Kingdom, DE22 3NE
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.
Exeter, Devon, United Kingdom, EX2 5DW
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.
Maidstone, Kent, United Kingdom, ME16 9QQ