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

Sponsor

Centre Georges Francois Leclerc (Other)

Overall Status

Completed

CT.gov ID

NCT03607149

Collaborator

(none)

Enrollment

Locations

Arms

34.5

Actual Duration (Months)

3.7

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non-small Cell Lung Cancer	Drug: Pemetrexed	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

11 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 6, 2017

Actual Primary Completion Date :

Feb 20, 2020

Actual Study Completion Date :

Feb 20, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: STANDARD ARM Calculation of the dose of pemetrexed as a function of body surface area	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)
Experimental: EXPERIMENTAL ARM Calculation of the pemetrexed dose as a function of the Clearance of creatine (CrCLCG)	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)

Arm

Intervention/Treatment

Active Comparator: STANDARD ARM

Calculation of the dose of pemetrexed as a function of body surface area

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)

Experimental: EXPERIMENTAL ARM

Calculation of the pemetrexed dose as a function of the Clearance of creatine (CrCLCG)

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)

Outcome Measures

Primary Outcome Measures

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

Progression-free survival [up to 100 weeks]
From date of randomization until the date of death from any cause

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	CH William Morey	Chalon-sur-Saône	France	71100
2	Centre Georges Francois Leclerc	Dijon	France	21079
3	Centre Universitaire Hospitalier de Dijon	Dijon	France	21079