IIIB and IV non-small cell lung cancer MedDRA version: 9.1 Level: LLT Classification code 10026532 Term: Malignant neoplasm of thorax
Conditions
Interventions
Trade Name: ALIMTA 1FL POLV 500MG
Pharmaceutical Form: Powder for infusion*
INN or Proposed INN: Pemetrexed
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Sponsors
ELI LILLY
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Histologically or citologically proven IIIB and IV non-small cell lung cancer. - Absence of symptomatic uncontrolled brain metastasis - Not suitable for platinum containing regimens if chemo-na ve or pretreated with regimens not containing Gemcitabine or Pemetrexed - A life expectancy of at least 12 weeks - Adequate bone marrow platelets 8805; 100 000 cells/L, absolute neutrophil count 8805; 1.5 x 109 cells/L, hemoglobin 8805; 9 g/dL. - Hepatic total bilirubin 8804; 1.5 times the upper limit of normal 61620; ULN , alkaline phosphatase AP , aspartate transaminase AST and alanine transaminase ALT 8804; 61472;3 61620; ULN AP, AST, and ALT 8804; 5 61620; ULN is acceptable if liver has tumor involvement . - Renal calculated creatinine clearance CrCl 8805; 45 mL/min based on the standard Cockroft and Gault formula or on measured glomerular filtration rate GFR using the appropriate radiolabeled method 51-CrEDTA or Tc99m-DTPA . Enrollment and dosing decisions based on creatinine clearance will be made using local lab values calculated using the standard Cockroft and Gault formula. The same method should be used throughout the study. 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: - Pregnant and/or lactating women are not allowed in this treatment. Male and female patients with reproductive potential must use an approved contraceptive method if appropriate for example, intrauterine device IUD , birth control pills, or barrier device during and for 3 months after the study. Female patients with childbearing potential must have a negative serum pregnancy test within 7 days prior to study enrollment. - Prior radiation to 25 of bone marrow - Inability to interrupt Aspirin at doses of 1.3 g/day or non-steroidal anti-inflammatory agents for a 5-day period 8-day period for long-acting agents, such as piroxicam . - Presence of clinically relevant 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. - Inability or unwillingness to take folic acid or vitamin B12. - Inability to take corticosteroids. - Diagnosis of myocardial infarction or significant cardiac disease - Have received treatment within the last 30 days with a drug not including study drug that has not received regulatory approval for any indication at the time of study entry.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The principal objective of the trial is to assess which is the proper time interval between pemetrexed and gemcitabine administration to optimize the synergism between the two drugs in the treatment of patients with advanced NSCLC.;Secondary Objective: Evaluation of tumor response rate. Evaluation of Toxicity.;Primary end point(s): In order to assess the best timing of Pemetrexed-gemcitabine administration and the most appropriate interval between the two drug doses, monitoring of dCK and hENT induction by Pemetrexed will be performed | — |
Countries
Italy
Outcome results
None listed