Clinical trial NCT03607149: Pemetrexed in Maintenance in Patients With Impaired Renal Function, 2 Dose Calculation Strategies
Official title: Pemetrexed in Maintenance in Patients With Impaired Renal Function: Randomized Phase 4 Multicenter Study Comparing 2 Dose Calculation Strategies (PKAPIR)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Non-small Cell Lung Cancer
Keywords: Pemetrexed
Non-small cell lung cancer
Clearance of creatine
Lead sponsor: Centre Georges Francois Leclerc
Sponsor class: OTHER
First posted: 2018-07-31
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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)

Primary outcomes:
measure: Median time until treatment is stopped due to renal function ≤ 45mL / min
timeFrame: 1 year
Secondary outcomes:
measure: Progression-free survival
timeFrame: up to 100 weeks
Other outcomes:
Locations:
city: Chalon-sur-Saône
country: France
facility: CH William Morey
city: Dijon
country: France
facility: Centre Georges Francois Leclerc
city: Dijon
country: France
facility: Centre Universitaire Hospitalier de Dijon
Study officials:
References: