PHARMACOKINETICS OF CARBOPLATIN AFTER ADJUSTED DOSING FOR HIGH BMI, LOW SERUM CREATININE, AND MAXIMAL RENAL FUNCTIO
- Conditions
- lung cancerovarian cancer10027656
- Registration Number
- NL-OMON44328
- Lead Sponsor
- ziekenhuisapotheek
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
- any type of histologically or cytologically proven solid tumor for which treatment with carboplatin is indicated
- to be treated with carboplatin with a target AUC of 4, 5 or 6
- age 18 years or older
- WHO status 0 - 2
- adequate bone marrow and liver function defined as
o haemoglobin >= 6.0 mmol/L
o white blood cell count >= 3.0 * 109/L
o absolute neutrophil count (ANC) >= 1.5 * 109/L
o platelets >= 100/L
o bilirubin <= 1.5 times ULN
o ALAT and ASAT <= 2.5 times ULN (in case of liver metastases <= 5.0 times ULN).
- estimated life expectancy of at least 12 weeks
- 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
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is the mean prediction error and the mean absolute<br /><br>prediction error in obtaining the target AUC of carboplatin using the new<br /><br>dosing algorithm. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints are additional pharmacokinetic parameters (including<br /><br>clearance, half life,) of carboplatin using the new dosing algorithm, the<br /><br>relationships between the clearance of carboplatin and the serum cystatine C<br /><br>value and the 24-hour urinary clearance, and safety of treatment defined as<br /><br>treatment-related toxicity, toxicity-related hospitalization and<br /><br>toxicity-related dose adjustments</p><br>