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 : June 24, 2020
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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 |
- 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 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 |

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) |
- 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
- 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 |
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)

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
Contact: Bruno COUDERT | 03 80 73 75 28 | bcoudert@cgfl.fr | |
Contact: Emilie REDERSTORFF | 03.45.34.81.16 | erederstorff@cgfl.fr |
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 |
Responsible Party: | Centre Georges Francois Leclerc |
ClinicalTrials.gov Identifier: | NCT03607149 |
Other Study ID Numbers: |
2016-002552-24 |
First Posted: | July 31, 2018 Key Record Dates |
Last Update Posted: | June 24, 2020 |
Last Verified: | January 2020 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Pemetrexed Non-small cell lung cancer Clearance of creatine |
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 |