Validation of an Adjusted Dosing Algorithm of Carboplatin
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|ClinicalTrials.gov Identifier: NCT02103244|
Recruitment Status : Unknown
Verified March 2014 by Rijnstate Hospital.
Recruitment status was: Not yet recruiting
First Posted : April 3, 2014
Last Update Posted : April 3, 2014
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Drug: Carboplatin||Phase 4|
Carboplatin is an alkylating anticancer drug that is used for the treatment of various types of cancer, including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), malignant mesothelioma, ovarian cancer, and breast cancer. It is mostly given in combination with other chemotherapeutic drugs, but it can also be given as single agent.
Since carboplatin is highly eliminated by the kidneys, the dose needs to be adjusted for renal dysfunction. Furthermore, as there is clear correlation between the area under the concentration-time curve (AUC) of carboplatin and haematological toxicity and response rate, carboplatin is dosed per target AUC. For this, the standard pharmacokinetic formula [dose = clearance carboplatin x target AUC] is used.
the clearance is typically calculated using the cockcroft and gault (C-G) formula. In patients with high weight, or very low serum creatinine values the C-G-formula may overestimate the renal function, resulting in a potential overdose of carboplatin. the new developed dosing algorithm to be studied adjusts for high BMI and low serum creatinine values, in order to provide a more safe dose of carboplatin
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pharmacokinetics of Carboplatin After Adjusted Dosing for High BMI, Low Serum Creatinine, and Maximal Renal Function|
|Study Start Date :||September 2014|
|Estimated Primary Completion Date :||September 2015|
|Estimated Study Completion Date :||December 2015|
An adjusted dosing algorithm will be applied to calculate the dose of carboplatin. in 24 patients blood will be obtained in order to determine the pharmacokinetics of carboplatin after adjusted dosing
carboplatin will be dosed according to newly developed dosing algorithm.
- to the determine the mean absolute precision error and the mean prediction error of the AUC of carboplatin after dosing carboplatin according to the new dosing algorithm [ Time Frame: 1 year ]
- Assessment of the incidence and severity of all adverse events that occurred during treatment with carboplatin [ Time Frame: 1 year ]
Treatment with carboplatin is associated with adverse drug reactions. As an oncolytic drug, treatment with carboplatin may for example result in myelosupression, infections and/or gastro-intestinal toxicity, that may require hospitalization for treatment of toxicity.
With the new dosing algorithm we hope to provide a better calculation of the appropriate dose for the individual patient, and thereby a safer treatment. Therefore, adverse events of treatment is an important secondary outcome measure that will be assessed.
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): NCT02103244
|Arnhem, Netherlands, 6815 AD|
|Contact: P. mg filius, PharmD, PhD +31880056322 firstname.lastname@example.org|
|Principal Investigator: P. mg filius, PharmD, PhD|
|Principal Investigator:||P. MG Filius, PharmD PhD||Rijnstate Hospital|