Paclitaxel Detection in NSCLC Treated With TC Regimen
Status:
Terminated
Trial end date:
2018-10-25
Target enrollment:
Participant gender:
Summary
By detecting the blood concentration of paclitaxel (PTX), Investigator assume this research
can identify the individual differences of PTX pharmacokinetics (PK) parameters (TC>0.05
refers to the duration of paclitaxel plasma concentration above 0.05 µmol/L) in Chinese
non-small cell lung cancer (NSCLC) patients, and find the correlation between PK results and
PTX toxicities and Effectiveness, acquire the optimization method of PTX, and finally try to
explore the individualized PTX pharmacokinetically-guided dosing strategy. Orally administer
rosiglitazone, which is a substrate of CYP2C8 the same as paclitaxel, before chemotherapy
injection. Detect the blood concentration of rosiglitazone, analyze the correlation of
rosiglitazone pharmacokinetic parameter and paclitaxel exposure, and explore the effect of
rosiglitazone as an in vivo probe of paclitaxel exposure.
1. The variability of paclitaxel concentrations in the patient population dosed by body
surface area (BSA), and the limitation of BSA-based dosing of paclitaxel.
2. Verify that paclitaxel TC>0.05 is the most relevant predictor of haematological toxicity
and clinical outcomes.
3. Define a dosing algorithm based on paclitaxel TC>0.05 of paclitaxel and quantify its
effect on both reducing toxicity and improving Effectiveness.
4. The effect of using dose modification and administration of G-CSF based on toxicity
determined by paclitaxel TC>0.05 measurement.
5. Construct a trial outline with the aim of reducing grade 4 neutropenia toxicity and
ensuring the clinical outcome by using individual dose adjustments based on the dosing
algorithm.
6. Detect the blood concentration of rosiglitazone after orally administration, explore the
effect of rosiglitazone as an in vivo probe of paclitaxel exposure based on CYP2C8
activity. Attempt to establish a model to predict the paclitaxel exposure of patients
base on rosiglitazone blood concentration before chemotherapy.