Validation of an Adjusted Dosing Algorithm of Carboplatin
Information source: Rijnstate Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cancer
Intervention: Carboplatin (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Rijnstate Hospital Official(s) and/or principal investigator(s): P. MG Filius, PharmD PhD, Principal Investigator, Affiliation: Rijnstate Hospital
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.
Clinical Details
Official title: Pharmacokinetics of Carboplatin After Adjusted Dosing for High BMI, Low Serum Creatinine, and Maximal Renal Function
Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 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
Secondary outcome: Assessment of the incidence and severity of all adverse events that occurred during treatment with carboplatin
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
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Rijnstate Hospital, Arnhem 6815 AD, Netherlands; Not yet recruiting P. mg filius, PharmD, PhD, Phone: +31880056322, Email: maarten.deenen@gmail.com P. mg filius, PharmD, PhD, Principal Investigator
Additional Information
Starting date: September 2014
Last updated: April 2, 2014
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