A Study of Thymidylate Synthase Expression in Patients With Non-Small Cell Lung Cancer

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

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 of non-squamous non-small cell lung cancer (NSCLC). The aim for the future is that doctors could have a better understanding in advance about which patients might respond well to pemetrexed based on how much TS they produce.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Cisplatin; Pemetrexed

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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