Locally advanced or metastatic Non-Small Cell Lung Cancer
Conditions
Interventions
Product Name: ALIMTA
Product Code: LY231514 disodium
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: pemetrexed
CAS Number: 150399-23-8
Current Sponsor code: LY231514 disod
Sponsors
Eli Lilly and Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Histologic or cytologic diagnosis of NSCLC Stage IIIB or IV No prior systemic chemotherapy for lung cancer At least one unidimensionally measurable lesion meeting Response Evaluation Criteria in Solid Tumors (RECIST), longest diameter ,10 mm with spiral computed tomography (CT) scan, or ,20 mm with conventional techniques.Positron emission tomography (PET) scans and ultrasounds should not be used for lesion measurements. ECOG performance status of 0 or 1 At least 18 years of age Adequate organ function, including the following: Adequate bone marrow reserve: absolute neutrophil (segmented and bands) count (ANC) ³1.5 ´ 109/L, platelets ³100 ´ 109/L, and hemoglobin ³9 g/dL.Hepatic: bilirubin £1.5 times the upper limit of normal (´ ULN), alkaline phosphatase (AP), aspartate transaminase (AST), and alanine transaminase (ALT) £3.0 ´ ULN (AP, AST, and ALT £5 ´ ULN is acceptable if the liver has tumor involvement) Renal: calculated creatinine clearance (CrCl) ³45 mL/minute based on the standard Cockcroft and Gault formula (Cockcroft and Gault 1976). Prior radiation therapy allowed to 12 weeks Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Peripheral neuropathy of > CTC grade 1 Serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient’s ability to complete the study. Serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease, as defined by the New York Heart Association Class III or IV. Second primary malignancy that is clinically detectable at the time of consideration for study enrollment. Documented brain metastatses unless the patient has completed successful local therapy for central nervous system metastases and has been off of corticosteroids for at least 4 weeks before enrollment. Brain imaging is required in symptomatic patients to rule out brain metastases, but is not required in asymptomatic patients. Presence of clinically detectable (by physical exam) third-space fluid collections, for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to study entry. Significant weight loss (that is > 10%) over the previous 6 weeks before study entry. Concurrent administration of any other antitumor therapy. Inability to interrupt aspirin or other non-steroidal anti-inflammatory agents for 5-day period (8-day period for long-actiong agents, such as piroxicam) Inability or unwillingness to take folic acid or vitamin B12. Inability to take corticosteroids
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare ALIMTA plus cisplatin with GEMZAR plus cisplatin in terms of the overall survival of previously untreated patients with Stage IIIB and IV NSCLC.;Secondary Objective: Compare between treatment arm: Time-to-event efficacy variables, including:Progression-free survival, Time to progressive disease, Duration of response, Time to treatment failure Objective tumor response Quantitative and qualitative laboratory and nonlaboratory toxicities Risk/benefit (toxicities relative to survival);Primary end point(s): Overall survival time | — |
Countries
Denmark, Finland, Hungary, Spain
Outcome results
None listed