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

Non-small Cell Lung Cancer Clinical Trial

— PKAPIR  

Official title:

Pemetrexed in Maintenance in Patients With Impaired Renal Function: Randomized Phase 4 Multicenter Study Comparing 2 Dose Calculation Strategies (PKAPIR)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03607149
• Other study ID #: 2016-002552-24
• Status: Completed
• Phase: Phase 4
• Start date: April 6, 2017
• Est. completion date: February 20, 2020

Study information

• Verified date: May 2021
• Source: Centre Georges Francois Leclerc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: February 20, 2020
• Est. primary completion date: February 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-small Cell Lung Cancer
• Renal Insufficiency

Intervention

Drug:
• Pemetrexed
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)

Locations

Country	Name	City	State
France	CH William Morey	Chalon-sur-Saône
France	Centre Georges Francois Leclerc	Dijon
France	Centre Universitaire Hospitalier de Dijon	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Georges Francois Leclerc

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median time until treatment is stopped due to renal function = 45mL / min	From date of randomization until the date of treatment is stopped	1 year
Secondary	Progression-free survival	From date of randomization until the date of death from any cause	up to 100 weeks