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Validation of an Adjusted Dosing Algorithm of Carboplatin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Rijnstate Hospital

Study Description
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Brief Summary:
An adjusted dosing algorithm for the dosing of the anticancer drug carboplatin has been developed, that accounts for high BMI, low serum creatinine values and maximal calculated renal function. The hypothesis is that this new dosing algorithm provides a more accurate and safe dose than dosing according to the old standard of care.

Condition or disease Intervention/treatment Phase
Cancer Drug: Carboplatin Phase 4

Detailed Description:

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Creatinine
Drug Information available for: Carboplatin

Arms and Interventions
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Arm Intervention/treatment
Experimental: carboplatin
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
 Drug: Carboplatin
carboplatin will be dosed according to newly developed dosing algorithm.


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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.



Eligibility Criteria
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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:

  • histologically or cytologically proven advanced NSCLC, SCLC or ovarian cancer
  • to be treated with carboplatin with a target AUC of 4, 5 or 6
  • age 18 years or older
  • WHO performance status 0 - 2

  • adequate bone marrow and liver function defined as

    • haemoglobin ≥ 6.0 mmol/L
    • white blood cell count ≥ 3.0 * 109/L
    • absolute neutrophil count (ANC) ≥ 1.5 * 109/L
    • platelets ≥ 100/L
    • bilirubin ≤ 1.5 times ULN
    • ALAT and ASAT ≤ 2.5 times ULN (in case of liver metastases ≤ 5.0 times ULN).
  • estimated life expectancy of at least 12 weeks

Exclusion Criteria:

  • Treatment with carboplatin with a target AUC of <4
  • active clinically serious infection
  • history of a kidney allograft
  • pregnant
  • patients not suitable for follow-up
  • pregnancy or breast-feeding
Contacts and Locations
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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): NCT02103244


Locations
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Netherlands
Rijnstate Hospital
Arnhem, Netherlands, 6815 AD
Contact: P. mg filius, PharmD, PhD    +31880056322    maarten.deenen@gmail.com   
Principal Investigator: P. mg filius, PharmD, PhD         
Sponsors and Collaborators
Rijnstate Hospital
Investigators
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Principal Investigator: P. MG Filius, PharmD PhD Rijnstate Hospital
More Information
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Responsible Party: Rijnstate Hospital
ClinicalTrials.gov Identifier: NCT02103244    
Other Study ID Numbers: CARBMI
First Posted: April 3, 2014    Key Record Dates
Last Update Posted: April 3, 2014
Last Verified: March 2014
Keywords provided by Rijnstate Hospital:
pharmacokinetics
safety
Additional relevant MeSH terms:
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Carboplatin
Antineoplastic Agents