Validation of an Adjusted Dosing Algorithm of Carboplatin
Pharmacokinetics of Carboplatin After Adjusted Dosing for High BMI, Low Serum Creatinine, and Maximal Renal Function
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 cancer
Started Sep 2014
Shorter than P25 for phase_4 cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 26, 2014
CompletedFirst Posted
Study publicly available on registry
April 3, 2014
CompletedStudy Start
First participant enrolled
September 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedApril 3, 2014
March 1, 2014
1 year
March 26, 2014
April 2, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (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
1 year
Secondary Outcomes (1)
Assessment of the incidence and severity of all adverse events that occurred during treatment with carboplatin
1 year
Study Arms (1)
carboplatin
EXPERIMENTALAn 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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rijnstate Hospital
Arnhem, 6815 AD, Netherlands
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
P. MG Filius, PharmD PhD
Rijnstate Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 26, 2014
First Posted
April 3, 2014
Study Start
September 1, 2014
Primary Completion
September 1, 2015
Study Completion
December 1, 2015
Last Updated
April 3, 2014
Record last verified: 2014-03