Non-Small Cell Lung Cancer
Conditions
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 information collected during this study will be analyzed by the Sponsor in the future to evaluate pemetrexed for other possible uses or for other medical or scientific purposes other than those currently proposed. Although pemetrexed has been shown to be effective in some patients with non-small-cell lung cancer, pemetrexed might not have beneficial effects for all patients.
Interventions
DRUGpemetrexed
A: 500 mg/m2, IV, q 21 days until disease progression B: 900 mg/m2, IV, q 21 days until disease progression
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | baseline to date of death from any cause |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival | baseline to measured progressive disease |
| Tumor response rate | baseline to measured progressive disease |
| Adverse events | every cycle |
Countries
Turkey (Türkiye)
Outcome results
None listed