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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STANDARD ARM | Active Comparator | Calculation of the dose of pemetrexed as a function of body surface area |
|
| EXPERIMENTAL ARM | Experimental | Calculation of the pemetrexed dose as a function of the Clearance of creatine (CrCLCG) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Median time until treatment is stopped due to renal function ≤ 45mL / min | From date of randomization until the date of treatment is stopped | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | From date of randomization until the date of death from any cause | up to 100 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH William Morey | Chalon-sur-Saône | 71100 | France | |||
| Centre Georges Francois Leclerc |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D000068437 | Pemetrexed |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 |
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| Dijon |
| 21079 |
| France |
| Centre Universitaire Hospitalier de Dijon | Dijon | 21079 | France |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |