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

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ClinicalTrials.gov Identifier: NCT03607149
Recruitment Status : Recruiting
First Posted : July 31, 2018
Last Update Posted : July 31, 2018
Sponsor:
Information provided by (Responsible Party):
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.


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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 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 : April 6, 2017
Estimated Primary Completion Date : September 6, 2020
Estimated Study Completion Date : January 6, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Tests

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)





Primary Outcome Measures :
  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 Outcome Measures :
  1. Progression-free survival [ Time Frame: up to 100 weeks ]
    From date of randomization until the date of death from any cause



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03607149


Contacts
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Contact: Bruno COUDERT 03 80 73 75 28 bcoudert@cgfl.fr
Contact: Emilie REDERSTORFF 03.45.34.81.16 erederstorff@cgfl.fr

Locations
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France
CH William Morey Not yet recruiting
Chalon-sur-Saône, France, 71100
Contact: Marie-Fleur QUILLOT       Fleur-marie.quilot@ch-chalon71.fr   
Contact: Jerome POIROT       jerome.poirot@ch-chalon71.fr   
Centre Georges Francois Leclerc Recruiting
Dijon, France, 21079
Contact: Bruno COUDERT    03 80 73 75 28    bcoudert@cgfl.fr   
Contact: Emilie REDERSTORFF    03.45.34.81.16    erederstorff@cgfl.fr   
Principal Investigator: Bruno COUDERT         
Sub-Investigator: Aurélie LAGRANGE         
Sub-Investigator: Laure FAVIER         
Centre Universitaire Hospitalier de Dijon Not yet recruiting
Dijon, France, 21079
Contact: Pascal FOUCHER    03 80 29 37 72    pascal.foucher@chu-dijon.fr   
Sponsors and Collaborators
Centre Georges Francois Leclerc

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Responsible Party: Centre Georges Francois Leclerc
ClinicalTrials.gov Identifier: NCT03607149     History of Changes
Other Study ID Numbers: PKAPIR
First Posted: July 31, 2018    Key Record Dates
Last Update Posted: July 31, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Georges Francois Leclerc:
Pemetrexed
Non-small cell lung cancer
Clearance of creatine
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Renal Insufficiency
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Kidney Diseases
Urologic Diseases
Pemetrexed
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors