Paclitaxel Detection in NSCLC Treated With TC Regimen
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|ClinicalTrials.gov Identifier: NCT02737709|
Recruitment Status : Terminated (The study have difficulty in recruiting subjectes)
First Posted : April 14, 2016
Last Update Posted : October 29, 2018
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.
- The variability of paclitaxel concentrations in the patient population dosed by body surface area (BSA), and the limitation of BSA-based dosing of paclitaxel.
- Verify that paclitaxel TC>0.05 is the most relevant predictor of haematological toxicity and clinical outcomes.
- Define a dosing algorithm based on paclitaxel TC>0.05 of paclitaxel and quantify its effect on both reducing toxicity and improving Effectiveness.
- The effect of using dose modification and administration of G-CSF based on toxicity determined by paclitaxel TC>0.05 measurement.
- 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.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer||Drug: Paclitaxel and Carboplatin regimen||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||51 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Clinical Experience Trial to Detect the Plasma Paclitaxel Drug Concentration in Chinese Non -Small Cell Lung Cancer (NSCLC) Patients Treated With a Paclitaxel Plus Carboplatin (TC) Regimens, and Explore Individualized Treatment Using Pharmacokinetically-guided Dosing Strategy|
|Study Start Date :||March 2016|
|Actual Primary Completion Date :||October 25, 2018|
|Actual Study Completion Date :||October 25, 2018|
Experimental: Paclitaxel and Carboplatin regimen
Paclitaxel: 175mg/m2, d1; Intravenous drip injection with 500ml N.S Carboplatin: AUC=5, d1; Intravenous drip injection with 500ml G.S Paclitaxel injection at first, followed with Carboplatin injection. 21 days per cycle; 6 cycles in total.
Drug: Paclitaxel and Carboplatin regimen
Chemotherapy regimen:Paclitaxel: 175mg/m2, d1; Intravenous drip injection with 500ml N.S；Carboplatin: AUC=5, d1; Intravenous drip injection with 500ml G.S Paclitaxel injection at first, followed with Carboplatin injection.
Other Name: treatment group
- Change of tumor sizes from baseline [ Time Frame: baseline; 6 weeks; 12 weeks; 18 weeks; 24 weeks; 32 weeks; up to 3 years. ]Object response rate (ORR): assess the ORR of paclitaxel/carboplatin chemotherapy according to Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
- Area under the plasma concentration versus time curve (AUC) of rosiglitazone [ Time Frame: 3 hours after rosiglitazone administration ]Detect the plasma concentration of rosiglitazone 3 hours after orally administration of rosiglitazone.
- The duration of paclitaxel plasma concentration above 0.05 µmol/L (TC>0.05) [ Time Frame: 5min before paclitaxel administration; and 24 hours after. ]Detect the blood concentration of paclitaxel 24 hours after the initiation, Calculate paclitaxel TC>0.05
- Toxicities rate [ Time Frame: day10, day21, day 31, day 42, day 52, day 63, day 73, day 84, day 94, day 105, day115 and day 126. ]Toxicities rate: assess the toxicities rate and severity of paclitaxel/carboplatin chemotherapy according to Common Terminology Criteria For Adverse Events (CTCAE) v4.03, and analyze the relationship of paclitaxel TC>0.05 and toxicities.
- progression free survival (months) [ Time Frame: From date of consent form until the date of first documented progression, up to 36 months. ]Survival Effectiveness: assess the progression free survival (PFS) of paclitaxel/carboplatin chemotherapy
- Overall survival (months) [ Time Frame: From date of consent form until the date of death from any cause, up to 36 months. ]Survival Effectiveness: assess the overall survival (OS) of paclitaxel/carboplatin chemotherapy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02737709
|Sun Yat-sen University Cancer Center|
|Guangzhou, Guangdong, China, 510060|
|Principal Investigator:||Li Zhang, M.D.||Sun Yat-sen University|