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

• Status: Completed
• Trial end date: 2020-02-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Georges Francois Leclerc
• Treatments: Pemetrexed

Criteria

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)