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

Phase 4

Completed

• Conditions: Non-small Cell Lung Cancer
• Interventions: Drug: Pemetrexed

• Registration Number: NCT03607149
• Lead Sponsor: Centre Georges Francois Leclerc

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.

Study Timeline

• Study Start: 2017-04-06
• Study First Submitted: 2017-06-21
• Study First Submitted QC: 2018-07-23
• Study First Posted: 2018-07-31
• Primary Completion: 2020-02-20
• Study Completion: 2020-02-20
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-21
• Last Update Posted: 2021-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
STANDARD ARM	Pemetrexed	Calculation of the dose of pemetrexed as a function of body surface area
EXPERIMENTAL ARM	Pemetrexed	Calculation of the pemetrexed dose as a function of the Clearance of creatine (CrCLCG)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Progression-free survival	up to 100 weeks	From date of randomization until the date of death from any cause

Trial Locations

Locations (3)

Centre Georges Francois Leclerc; 🇫🇷 Dijon, France

CH William Morey; 🇫🇷 Chalon-sur-Saône, France

Centre Universitaire Hospitalier de Dijon; 🇫🇷 Dijon, France