Clinical trial · Interventional
Explore the Individual Treatment of Docetaxel and Paclitaxel in NSCLC, NPC and BRC by PK-guided Dosing Strategy
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 populations. DTX exposures measured by area under plasma concentration-time curve (AUC), PTX exposures measured by the time above a plasma concentration of 0.05 µmol/L (TC\>0.05), are the most biologic effects associated PK parameters for DTX and PTX, respectively, which could positively predict related toxicities such as neutropenia, peripheral neuropathy, etc. So, we conducted a randomized clinical trial to compare the effect on related toxicities and efficacy of PK-guided dosing strategy and BSA dosing strategy.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Nasal Cancer | — | UNRESOLVED | — |
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PK guided arm | Device | — | UNRESOLVED |
| PTX 175mg/m2, DOC 75mg/m2 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- body surface area
- description
- 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
- interventionNames
- Drug: PTX 175mg/m2, DOC 75mg/m2
- type
- ACTIVE_COMPARATOR
- label
- Detection Kit
- description
- 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
- interventionNames
- Device: PK guided arm
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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
References
Publications (39)
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- BACKGROUNDMiyaushiro S, Kitanaka A, Kubuki Y, Hidaka T, Shide K, Kameda T, Sekine M, Kamiunten A, Umekita Y, Kawabata T, Ishiguro Y, Shimoda K. Nasopharyngeal carcinoma with bone marrow metastasis: positive response to weekly paclitaxel chemotherapy. Intern Med. 2015;54(11):1455-9. doi: 10.2169/internalmedicine.54.3917. Epub 2015 Jun 1. PMID 26028007
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- BACKGROUNDTan EH, Khoo KS, Wee J, Fong KW, Lee KS, Lee KM, Chua ET, Tan T, Khoo-Tan HS, Yang TL, Au E, Tao M, Ong YK, Chua EJ. Phase II trial of a paclitaxel and carboplatin combination in Asian patients with metastatic nasopharyngeal carcinoma. Ann Oncol. 1999 Feb;10(2):235-7. doi: 10.1023/a:1008390929826. PMID 10093695
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- BACKGROUNDBaker SD, Verweij J, Rowinsky EK, Donehower RC, Schellens JH, Grochow LB, Sparreboom A. Role of body surface area in dosing of investigational anticancer agents in adults, 1991-2001. J Natl Cancer Inst. 2002 Dec 18;94(24):1883-8. doi: 10.1093/jnci/94.24.1883.