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NCT Number: NCT03607149

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

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.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CH William Morey, Chalon-sur-Saône, France

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About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Pemetrexed

Drug

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 outcomes

  1. Median time until treatment is stopped due to renal function ≤ 45mL / min

    Time frame: 1 year

    From date of randomization until the date of treatment is stopped

Secondary outcomes

  1. Progression-free survival

    Time frame: up to 100 weeks

    From date of randomization until the date of death from any cause

Sponsors and collaborators

Lead sponsor

Centre Georges Francois Leclerc

Other

Registry information

Official study title

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

Acronym: PKAPIR

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jul 31, 2018
Registry last updated
May 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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