Non-small Cell Lung Cancer
Conditions
Keywords
Pemetrexed, Non-small cell lung cancer, Clearance of creatine
Brief summary
Pemetrexed is used in the treatment of non-small cell lung cancer (NSCLC). Its elimination is mainly renal and its nephrotoxicity requires an interruption of treatment when the CrCLCG falls below 45 mL / min. Patients with NSCLC frequently have impaired renal function by other cytotoxic drugs. The dose adjustment of pemetrexed is performed as a function of body surface area (SC) without any pharmacokinetic rational. The challenge is to treat patients with renal insufficiency (RR) with a safe dose, based on CRCL, providing equivalent biological exposure to patients with preserved renal function.
Detailed description
* Primary objective: Evaluate the impact of calculating the dose of pemetrexed to be administered versus creatine clearance according to Cockcroft-Gault (CrCLCG) versus body surface area (SC) on median time before discontinuation of treatment for renal function ≤ 45mL / min in patients treated for non-small cell lung cancer predominantly non-squamous in maintenance. * Secondary objective: To evaluate the impact of calculating the dose of pemetrexed to be administered versus CRCLCG versus SC over time to treatment discontinuation, progression-free survival (PFS), and patient overall survival.
Interventions
DRUGPemetrexed
standard arm : calculating the dose of pemetrexed according to body surface area experimental arm: calculation of the dose of pemetrexed as a function of creatinine clearance (CrCLCG)
Sponsors
Centre Georges Francois Leclerc
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
* Patient over 18 years of age * Patient with non-small cell lung cancer predominantly non-epidermoid histologically documented * Patient who is scheduled to initiate treatment or undergoing maintenance therapy by pemetrexed * Neutrophils\> 1500 / mm3; Chips\> 100,000 / mm3 * Informed, dated and signed consent For patients of childbearing age, effective contraceptive method * Creatinine clearance according to the Cockcroft-Gault formula between 70 and 45 mL / min * PS = 0 or 1
Exclusion criteria
* Patient with a contraindication to pemetrexed therapy * Patient with symptomatic brain metastases * Pregnant or nursing women * Patient under guardianship or curatorship or subject to a system of protection for persons of full age * Patient not affiliated to a social security scheme (beneficiary or beneficiary)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median time until treatment is stopped due to renal function ≤ 45mL / min | 1 year | From date of randomization until the date of treatment is stopped |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | up to 100 weeks | From date of randomization until the date of death from any cause |
Countries
France
Outcome results
None listed