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

Primary Purpose

Non-small Cell Lung Cancer

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Pemetrexed
Sponsored by
Centre Georges Francois Leclerc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring Pemetrexed, Non-small cell lung cancer, Clearance of creatine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • CH William Morey
  • Centre Georges Francois Leclerc
  • Centre Universitaire Hospitalier de Dijon

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

STANDARD ARM

EXPERIMENTAL ARM

Arm Description

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

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

Outcomes

Primary Outcome Measures

Median time until treatment is stopped due to renal function ≤ 45mL / min
From date of randomization until the date of treatment is stopped

Secondary Outcome Measures

Progression-free survival
From date of randomization until the date of death from any cause

Full Information

First Posted
June 21, 2017
Last Updated
May 21, 2021
Sponsor
Centre Georges Francois Leclerc
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1. Study Identification

Unique Protocol Identification Number
NCT03607149
Brief Title
Pemetrexed in Maintenance in Patients With Impaired Renal Function, 2 Dose Calculation Strategies
Acronym
PKAPIR
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

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
April 6, 2017 (Actual)
Primary Completion Date
February 20, 2020 (Actual)
Study Completion Date
February 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Georges Francois Leclerc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
Pemetrexed, Non-small cell lung cancer, Clearance of creatine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
STANDARD ARM
Arm Type
Active Comparator
Arm Description
Calculation of the dose of pemetrexed as a function of body surface area
Arm Title
EXPERIMENTAL ARM
Arm Type
Experimental
Arm Description
Calculation of the pemetrexed dose as a function of the Clearance of creatine (CrCLCG)
Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Intervention Description
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)
Primary Outcome Measure Information:
Title
Median time until treatment is stopped due to renal function ≤ 45mL / min
Description
From date of randomization until the date of treatment is stopped
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Progression-free survival
Description
From date of randomization until the date of death from any cause
Time Frame
up to 100 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
CH William Morey
City
Chalon-sur-Saône
ZIP/Postal Code
71100
Country
France
Facility Name
Centre Georges Francois Leclerc
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Centre Universitaire Hospitalier de Dijon
City
Dijon
ZIP/Postal Code
21079
Country
France

12. IPD Sharing Statement

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

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