Explore the Individual Treatment of Docetaxel and Paclitaxel in NSCLC, NPC and BRC by PK-guided Dosing Strategy
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|ClinicalTrials.gov Identifier: NCT01891123|
Recruitment Status : Unknown
Verified December 2015 by Li Zhang, Sun Yat-sen University.
Recruitment status was: Recruiting
First Posted : July 2, 2013
Last Update Posted : December 9, 2015
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer Breast Cancer Nasal Cancer||Device: PK guided arm Drug: PTX 175mg/m2, DOC 75mg/m2||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label Randomized Clinical Trial to Compare the Toxicities and Efficacy of Pharmacokinetically-guided and BSA Fixed Dosing Strategy of Docetaxel and Paclitaxel in Chinese Non-small Cell Lung Cancer, Nasopharyngeal Carcinoma, and Breast Cancer Patients.|
|Study Start Date :||June 2013|
|Estimated Primary Completion Date :||June 2016|
|Estimated Study Completion Date :||December 2016|
Placebo Comparator: body surface area
patients receive fixed dose of PTX or DOC based on body surface area every cycle, PTX 175mg/m2, DOC 75mg/m2. Patients should finish up to 6 cycles chemotherapy
Drug: PTX 175mg/m2, DOC 75mg/m2
patients receive PTX or DOC dose based on body surface area every cycle, PTX 175mg/m2, DOC 75mg/m2
Active Comparator: Detection Kit
PTX 175mg/m2, DOC 75mg/m2 at first cycle. the dose of PTX or DOC will adjust based on the pharmacokinetic results of previous cycle. A optimal target of PTX(TC>0.05) and DOC(AUC) have been set from published PK model with an established limited sampling strategy
Device: PK guided arm
the dose of PTX or DOC will adjust based on the plasma drug concentration of previous cycle
Other Name: pharmacokinetic guided dosing stratety
- Toxicities rate [ Time Frame: 3 weeks, 6 weeks, 9 weeks, 12 weeks, 15 weeks, 18weeks ]assess the toxicities rate and severity according to CTCAE v4.03, record the toxicities incident and grades from the first cycle to last cycle until the toxicities relieve or stabilize.
- Object response rate [ Time Frame: up to 18 weeks ]assess the ORR according to RECIST v1.1, An imaging examination should be performed in 4weeks before treatment initiation, and patients are going to receive (CT or MR scan) every 2 cycles during the treatment, the methods should be identical with baseline.
- Survival Effectiveness [ Time Frame: 36 months ]after treatment discontinuation, PFS is recorded by imaging examination every 2 cycles (8 weeks) until tumor progression, other anti-cancer treatment start, trial ends or death. OS is recorded by clinic follow-up or telephone follow-up until death.
- the quality of life of patients [ Time Frame: 3 weeks, 6 weeks, 9 weeks, 12 weeks, 15 weeks, 18weeks ]
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): NCT01891123
|Contact: YuXiang Mafirstname.lastname@example.org|
|Sun Yat-Sen University Cancer Center||Recruiting|
|GuangZhou, Guangdong, China, 510030|
|Contact: YuXiang Ma 8602087343786 email@example.com|
|Principal Investigator:||Li Zhang||Sun Yat-sen University|
|Principal Investigator:||Shu Sen Wang||Sun Yat-sen University|