Pemetrexed in Maintenance in Patients With Impaired Renal Function, 2 Dose Calculation Strategies (PKAPIR)

Centre Georges Francois Leclerc

Status and phase

Completed

Phase 4

Conditions

Non-small Cell Lung Cancer

Treatments

Drug: Pemetrexed

Study type

Interventional

Funder types

Other

Identifiers

NCT03607149

2016-002552-24

Details and patient eligibility

About

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.

Full 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.

Enrollment

11 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)