Status:
UNKNOWN
Explore the Individual Treatment of Docetaxel and Paclitaxel in NSCLC, NPC and BRC by PK-guided Dosing Strategy
Lead Sponsor:
Sun Yat-sen University
Conditions:
Non-small Cell Lung Cancer
Breast Cancer
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
As cytotoxic agents, DTX and PTX have a narrow therapeutic window. BSA dosing leads to great inter-individual PK variability, which is a major contributor for severe toxicity, especially in East-Asian...
Detailed Description
3 populations were included: advanced NSCLC patients receive a single-agent docetaxel regimen palliative chemotherapy without restriction of lines; NPC patients receive paclitaxel and carboplatin doub...
Eligibility Criteria
Inclusion
- Confirmed by pathology for advanced non small cell lung cancer, suitable for paclitaxel or docetaxel chemotherapy (clinical stage IV according to 2009 IASLC staging or recurrent NSCLC; receiving palliative chemotherapy independent of lines)
- ECOG PS score: 0 to 2 points
- Survival is expected to more than 3 month
- Bone marrow reserve function is good, the function of organs (liver and kidney) is good, can satisfy the conditions of implementation chemotherapy.
- Sign the informed consent form
- Compliance is good, can be followed up, willing to comply with the requirements of the study
Exclusion
- Physical status score (ECOG) greater than 2
- organic disease；Severely active infection；Organ transplantation immune therapy；Can't complete with in four to six cycles of chemotherapy
- Bone marrow, liver and kidney dysfunction, clinical doctors identify intolerance to chemotherapy
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2016
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT01891123
Start Date
June 1 2013
End Date
December 1 2016
Last Update
December 9 2015
Active Locations (1)
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1
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China, 510030