Conditions for which carboplatin is indicated for: 1. Advanced ovarian carcinoma of epithelial origin in: - first line therapy - second line therapy, after other treatments have failed. 2. Small cell carcinoma of the lung, in association with other chemotherapeutic agents.
Conditions
Interventions
Trade Name: Carboplatin 10mg/ml Concentrate for Infusion
Pharmaceutical Form: Injection*
Sponsors
Oxford Radcliffe Hospitals NHS Trust (Cancer Research UK Medical Oncology Unit, Churchill Hospital)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients aged over 18. - Eligible to receive carboplatin as single agent or in combination therapy, according to institutional guidelines. - At least two planned carboplatin cycles. - Ability to give informed consent. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Patients with ascites, oedema, or other expanded body space. - Patients receiving intravenous (IV) hydration therapy. - Pregnancy or breast feeding. - Patients who do not understand the Patient Information sheet in English. (Considering the size and purpose of this study, it would not be economically feasible to provide separate information material in other languages for anyone who does not fully understand the Patient Information).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the study is to evaluate the concept of dose-banding using pharmacokinetic measures (AUC, AUMC, Cmax, tmax) as surrogates for tissue drug exposure. ("Dose-banding" is a method of fitting the chemotherapy dose calculated for each patient to pre-defined "bands" or dose-ranges, and providing these with standard, pre-prepared infusions). ;Secondary Objective: To determine if the relationships between pharmacokinetic measures (AUC, AUMC, Cmax, tmax) and pharmacodynamic measures (thrombocytopenia) for carboplatin are influenced by dose-banding, as opposed to individualised dosing.; Primary end point(s): Deviation in observed target area under the plasma concentration - time curve (AUC) from predicted target AUC, when carboplatin doses are determined with the Calvert-formula* (Dose (mg) = AUC (mg x min/ml) x (Glomerular Filtration Rate (GFR, ml/min) + 25)). This will be studied following exact individualised dosing and dose-banding, respectively. *Reference: Calvert AH, Newell DR, Gumbrell LA, et al. Carboplatin dosage: prospective evaluation of a simple formula based on renal function. J Clin Oncol 1989,7:1748-1756. | — |
Countries
United Kingdom
Outcome results
None listed