non-small cell lung cancer, small cell lung cancer, ovarian cancer
Conditions
Interventions
Trade Name: carboplatin
Pharmaceutical Form:
INN or Proposed INN: carboplatin
Other descriptive name: CARBOPLATIN
Concentration unit: g gram(s)
Concentration type: up to
Concentration number: 0.9-
Sponsors
rijnstate hospital, the netherlands
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following 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 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 18 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 6
Exclusion criteria
Exclusion criteria: Female patients should not be pregnant or breast-feeding. Female patients with childbearing potential should agree to use effective, non-hormonal means of contraception during the study and for a period of at least 6 months following the last administration of study drugs. - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to determine the mean prediction error (MPE) and mean absolute prediction error (MAPE) of the area under the plasma concentration-time curve (AUC) of carboplatin after adjusted dosing for high BMI (BMI = 25 kg/m2), low serum creatinine (serum creatinine < 60µm/L), and maximal renal function (GFR = 125 ml/min).;Secondary Objective: Secondary objectives are: - to determine the safety of carboplatin after adjusted dosing for high BMI, low serum creatinine, and maximal renal function - to determine the relationship between the measured creatinine clearance, as measured by collection of a 24-hour urine sample, and the pharmacokinetics of carboplatin after adjusted dosing for high BMI, low serum creatinine, and maximal renal function - to determine the correlation between the measured 24-hour urinary creatinine clearance and the calculated clearance using the adjusted Cockcroft-Gault formula (adjusted for high BMI, low serum creatinine and maximal renal function) - to determine the relationship between serum cystatine C and the pharmacokinetics of carboplatin ;Primary end point(s): The primary endpoint is the mean prediction error and the mean absolute prediction error in obtaining the target AUC of carboplatin using the new dosing algorithm . ;Timepoint(s) of evaluation of this end point: Day one of the first adminstration of carboplatin | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints are additional pharmacokinetic parameters (including clearance, half life,) of carboplatin using the new dosing algorithm, and safety of treatment defined as treatment-related toxicity, toxicity-related hospitalization and toxicity-related dose adjustments. ;Timepoint(s) of evaluation of this end point: day one of the first administration of carboplatin, and time interval during which the patient is treated with carboplatin | — |
Countries
Netherlands
Contacts
Public Contactdr. P.M.G. Filius
rijnstate hospital, the netherlands
Outcome results
None listed