Non-small Cell Lung CancerNCT01891123
Explore the Individual Treatment of Docetaxel and Paclitaxel in NSCLC, NPC and BRC by PK-guided Dosing Strategy
A study testing PK guided arm and PTX 175mg/m2, DOC 75mg/m2 in people with Non-small Cell Lung Cancer and Breast Cancer, run by Sun Yat-sen University at 1 site in China.
Trial 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 populations. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-small Cell Lung Cancer, Breast Cancer, Nasal Cancer
- What is being tested?
- PK guided arm and PTX 175mg/m2, DOC 75mg/m2
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Jun 2013to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, 510030
YuXiang Ma, 8602087343786, mayx@sysucc.org.cn
About this study
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.
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.
Read the 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 doublet regimen whether as induction chemotherapy for local advanced patients or palliative chemotherapy for metastatic patients; BRC patients receive a single-agent docetaxel regimen after 4 cycles of adriamycin and cyclophosphamide for adjuvant chemotherapy. Patients are randomly assigned into the BSA-based dosing group and pharmacokinetically-guided dosing group. In the BSA-based dosing group, NPC patients receive paclitaxel (175mg/m2) and carboplatin (AUC=5) treatment, NSCLC and BRC patients receive docetaxel (75mg/m2) treatment, 3-weekly and for up to 6 cycles. BSA group and PK-guided group are with a same starting dose. DTX exposure (AUC) and PTX exposure (TC>0.05) are calculated from a published PK model with an established limited sampling strategy. Dose of subsequent cycles of PK-guided group patients is calculated base on the previous cycle PK results, according to optimal target algorithm. The optimal target for DTX exposure is 2.5 - 3.7 µg•h/mL. Dose reductions were permitted in both arms according to instructions. The study had a power of 80% to detect a 23% reduction of grade >3 neutropenia with PK-guided arm for DTX sub-study in NSCLC. A sample size of 100 NSCLC patients was estimated by using Fisher's exact test to provide a 5% two-sided alpha significance level to observe a decrease in the hematological toxicity with a power of 0.8. This is based on the reported toxicity rates of 85% with dose of 75mg/m2 and 63% with 60mg/m2. Objective response rate is evaluated by imaging examination (CT or MR scan) every 2 cycles. Toxicities are evaluated by patients' diary for toxicity reports and physician's evaluation at day 10 and day 21 at every cycle. Blood samples are collected every cycle. And survival information is collected by clinic and telephone follow-up. Research Hypothesis: 1. The concentrations variability dosed by BSA, and the limitation of BSA- and MTD-based dosing. 2. Verify that paclitaxel TC>0.05 and docetaxel AUC are the most relevant predictor of related toxicities and clinical outcomes. 3. Verify the feasibility of dosing algorithm based on paclitaxel TC>0.05 and docetaxel AUC, 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 and docetaxel AUC measurement. 5. Prove the ability of PK-guided dosing strategy in reducing DTX and PTX related hematologic and non-hematologic toxicities, and the effect on treatment efficacy.
- Conditions
- Non-small Cell Lung Cancer, Breast Cancer, Nasal Cancer
- Being tested
- PK guided arm, PTX 175mg/m2, DOC 75mg/m2
- Keywords
- Non-small Cell Lung Cancer, Breast cancer, plasma drug concentration, Nasopharygeal carcinoma
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Breast Neoplasms, Nose Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PK guided armDevice
Also called pharmacokinetic guided dosing stratety
the dose of PTX or DOC will adjust based on the plasma drug concentration of previous cycle
PTX 175mg/m2, DOC 75mg/m2Drug
patients receive PTX or DOC dose based on body surface area every cycle, PTX 175mg/m2, DOC 75mg/m2
| Study group | Role | What they receive |
|---|---|---|
| body surface area | Placebo comparator | 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 Receives: Drug: PTX 175mg/m2, DOC 75mg/m2 |
| Detection Kit | Active comparator | 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 Receives: Device: PK guided arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicities rate
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.
Measured: 3 weeks, 6 weeks, 9 weeks, 12 weeks, 15 weeks, 18weeks
Secondary outcomes (2)
Object response rate
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.
Measured: up to 18 weeks
Survival Effectiveness
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.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2013 (estimated)
- Study startJun 2013
- Primary completionJun 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (39)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Zhang, Sun Yat-sen University
- Investigators
- Li Zhang, Principal investigator, Sun Yat-sen UniversityShu Sen Wang, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01891123
- Sponsor's protocol ID
- DT0508
- Status last verified
- Dec 2015
- First submitted
- 18 Jun 2013
- Last updated
- 9 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cao SM, Simons MJ, Qian CN. The prevalence and prevention of nasopharyngeal carcinoma in China. Chin J Cancer. 2011 Feb;30(2):114-9. doi: 10.5732/cjc.010.10377.
PubMed 21272443Chan AT, Ma BB, Lo YM, Leung SF, Kwan WH, Hui EP, Mok TS, Kam M, Chan LS, Chiu SK, Yu KH, Cheung KY, Lai K, Lai M, Mo F, Yeo W, King A, Johnson PJ, Teo PM, Zee B. Phase II study of neoadjuvant carboplatin and paclitaxel followed by radiotherapy and concurrent cisplatin in patients with locoregionally advanced nasopharyngeal carcinoma: therapeutic monitoring with plasma Epstein-Barr virus DNA. J Clin Oncol. 2004 Aug 1;22(15):3053-60. doi: 10.1200/JCO.2004.05.178.
PubMed 15284255Miyaushiro 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.
PubMed 26028007Ciuleanu TE, Fountzilas G, Ciuleanu E, Plataniotis M, Todor N, Ghilezan N. Paclitaxel and carboplatin in relapsed or metastatic nasopharyngeal carcinoma: a multicenter phase II study. J BUON. 2004 Apr-Jun;9(2):161-5.
PubMed 17415808Tan 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.
PubMed 10093695Undevia SD, Gomez-Abuin G, Ratain MJ. Pharmacokinetic variability of anticancer agents. Nat Rev Cancer. 2005 Jun;5(6):447-58. doi: 10.1038/nrc1629.
PubMed 15928675Baker 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.
PubMed 12488482Engels FK, Loos WJ, van der Bol JM, de Bruijn P, Mathijssen RH, Verweij J, Mathot RA. Therapeutic drug monitoring for the individualization of docetaxel dosing: a randomized pharmacokinetic study. Clin Cancer Res. 2011 Jan 15;17(2):353-62. doi: 10.1158/1078-0432.CCR-10-1636. Epub 2011 Jan 11.
PubMed 21224369Rudek MA, Sparreboom A, Garrett-Mayer ES, Armstrong DK, Wolff AC, Verweij J, Baker SD. Factors affecting pharmacokinetic variability following doxorubicin and docetaxel-based therapy. Eur J Cancer. 2004 May;40(8):1170-8. doi: 10.1016/j.ejca.2003.12.026.
PubMed 15110880Bruno R, Hille D, Riva A, Vivier N, ten Bokkel Huinnink WW, van Oosterom AT, Kaye SB, Verweij J, Fossella FV, Valero V, Rigas JR, Seidman AD, Chevallier B, Fumoleau P, Burris HA, Ravdin PM, Sheiner LB. Population pharmacokinetics/pharmacodynamics of docetaxel in phase II studies in patients with cancer. J Clin Oncol. 1998 Jan;16(1):187-96. doi: 10.1200/JCO.1998.16.1.187.
PubMed 9440742Rosing H, Lustig V, van Warmerdam LJ, Huizing MT, ten Bokkel Huinink WW, Schellens JH, Rodenhuis S, Bult A, Beijnen JH. Pharmacokinetics and metabolism of docetaxel administered as a 1-h intravenous infusion. Cancer Chemother Pharmacol. 2000;45(3):213-8. doi: 10.1007/s002800050032.
PubMed 10663639Bruno R, Vivier N, Veyrat-Follet C, Montay G, Rhodes GR. Population pharmacokinetics and pharmacokinetic-pharmacodynamic relationships for docetaxel. Invest New Drugs. 2001 May;19(2):163-9. doi: 10.1023/a:1010687017717.
PubMed 11392450Baker SD, Li J, ten Tije AJ, Figg WD, Graveland W, Verweij J, Sparreboom A. Relationship of systemic exposure to unbound docetaxel and neutropenia. Clin Pharmacol Ther. 2005 Jan;77(1):43-53. doi: 10.1016/j.clpt.2004.09.005.
PubMed 15637530Extra JM, Rousseau F, Bruno R, Clavel M, Le Bail N, Marty M. Phase I and pharmacokinetic study of Taxotere (RP 56976; NSC 628503) given as a short intravenous infusion. Cancer Res. 1993 Mar 1;53(5):1037-42.
PubMed 8094996Minami H, Kawada K, Sasaki Y, Igarashi T, Saeki T, Tahara M, Itoh K, Fujii H. Pharmacokinetics and pharmacodynamics of protein-unbound docetaxel in cancer patients. Cancer Sci. 2006 Mar;97(3):235-41. doi: 10.1111/j.1349-7006.2006.00166.x.
PubMed 16542221
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01891123
- Acronym / sponsor ID
- DT0508
- Conditions
- Non-small Cell Lung Cancer, Breast Cancer, Nasal Cancer
- Keywords
- Non-small Cell Lung Cancer, Breast cancer, plasma drug concentration, Nasopharygeal carcinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 2 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 doublet regimen whether as induction chemotherapy for local advanced patients or palliative chemotherapy for metastatic patients; BRC patients receive a single-agent docetaxel regimen after 4 cycles of adriamycin and cyclophosphamide for adjuvant chemotherapy. Patients are randomly assigned into the BSA-based dosing group and pharmacokinetically-guided dosing group. In the BSA-based dosing group, NPC patients receive paclitaxel (175mg/m2) and carboplatin (AUC=5) treatment, NSCLC and BRC patients receive docetaxel (75mg/m2) treatment, 3-weekly and for up to 6 cycles. BSA group and PK-guided group are with a same starting dose. DTX exposure (AUC) and PTX exposure (TC>0.05) are calculated from a published PK model with an established limited sampling strategy. Dose of subsequent cycles of PK-guided group patients is calculated base on the previous cycle PK results, according to optimal target algorithm. The optimal target for DTX exposure is 2.5 - 3.7 µg•h/mL. Dose reductions were permitted in both arms according to instructions. The study had a power of 80% to detect a 23% reduction of grade >3 neutropenia with PK-guided arm for DTX sub-study in NSCLC. A sample size of 100 NSCLC patients was estimated by using Fisher's exact test to provide a 5% two-sided alpha significance level to observe a decrease in the hematological toxicity with a power of 0.8. This is based on the reported toxicity rates of 85% with dose of 75mg/m2 and 63% with 60mg/m2. Objective response rate is evaluated by imaging examination (CT or MR scan) every 2 cycles. Toxicities are evaluated by patients' diary for toxicity reports and physician's evaluation at day 10 and day 21 at every cycle. Blood samples are collected every cycle. And survival information is collected by clinic and telephone follow-up. Research Hypothesis: 1. The concentrations variability dosed by BSA, and the limitation of BSA- and MTD-based dosing. 2. Verify that paclitaxel TC>0.05 and docetaxel AUC are the most relevant predictor of related toxicities and clinical outcomes. 3. Verify the feasibility of dosing algorithm based on paclitaxel TC>0.05 and docetaxel AUC, 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 and docetaxel AUC measurement. 5. Prove the ability of PK-guided dosing strategy in reducing DTX and PTX related hematologic and non-hematologic toxicities, and the effect on treatment efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| body surface area | Placebo comparator | Drug: PTX 175mg/m2, DOC 75mg/m2patients 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 |
| Detection Kit | Active comparator | Device: PK guided armPTX 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PK guided armAlso: pharmacokinetic guided dosing stratetythe dose of PTX or DOC will adjust based on the plasma drug concentration of previous cycle | Device | Detection Kit |
| PTX 175mg/m2, DOC 75mg/m2patients receive PTX or DOC dose based on body surface area every cycle, PTX 175mg/m2, DOC 75mg/m2 | Drug | body surface area |
Primary outcome
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.
2 secondary outcomes
Object response rate
Time frame: up to 18 weeks
Survival Effectiveness
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2015.
- Background: PubMed 21272443Cao SM, Simons MJ, Qian CN. The prevalence and prevention of nasopharyngeal carcinoma in China. Chin J Cancer. 2011 Feb;30(2):114-9. doi: 10.5732/cjc.010.10377.
- Background: PubMed 15284255Chan AT, Ma BB, Lo YM, Leung SF, Kwan WH, Hui EP, Mok TS, Kam M, Chan LS, Chiu SK, Yu KH, Cheung KY, Lai K, Lai M, Mo F, Yeo W, King A, Johnson PJ, Teo PM, Zee B. Phase II study of neoadjuvant carboplatin and paclitaxel followed by radiotherapy and concurrent cisplatin in patients with locoregionally advanced nasopharyngeal carcinoma: therapeutic monitoring with plasma Epstein-Barr virus DNA. J Clin Oncol. 2004 Aug 1;22(15):3053-60. doi: 10.1200/JCO.2004.05.178.
- Background: PubMed 26028007Miyaushiro 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.
- Background: PubMed 17415808Ciuleanu TE, Fountzilas G, Ciuleanu E, Plataniotis M, Todor N, Ghilezan N. Paclitaxel and carboplatin in relapsed or metastatic nasopharyngeal carcinoma: a multicenter phase II study. J BUON. 2004 Apr-Jun;9(2):161-5.
- Background: PubMed 10093695Tan 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.
- Background: PubMed 15928675Undevia SD, Gomez-Abuin G, Ratain MJ. Pharmacokinetic variability of anticancer agents. Nat Rev Cancer. 2005 Jun;5(6):447-58. doi: 10.1038/nrc1629.
- Background: PubMed 12488482Baker 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.
- Background: PubMed 21224369Engels FK, Loos WJ, van der Bol JM, de Bruijn P, Mathijssen RH, Verweij J, Mathot RA. Therapeutic drug monitoring for the individualization of docetaxel dosing: a randomized pharmacokinetic study. Clin Cancer Res. 2011 Jan 15;17(2):353-62. doi: 10.1158/1078-0432.CCR-10-1636. Epub 2011 Jan 11.
- Background: PubMed 15110880Rudek MA, Sparreboom A, Garrett-Mayer ES, Armstrong DK, Wolff AC, Verweij J, Baker SD. Factors affecting pharmacokinetic variability following doxorubicin and docetaxel-based therapy. Eur J Cancer. 2004 May;40(8):1170-8. doi: 10.1016/j.ejca.2003.12.026.
- Background: PubMed 9440742Bruno R, Hille D, Riva A, Vivier N, ten Bokkel Huinnink WW, van Oosterom AT, Kaye SB, Verweij J, Fossella FV, Valero V, Rigas JR, Seidman AD, Chevallier B, Fumoleau P, Burris HA, Ravdin PM, Sheiner LB. Population pharmacokinetics/pharmacodynamics of docetaxel in phase II studies in patients with cancer. J Clin Oncol. 1998 Jan;16(1):187-96. doi: 10.1200/JCO.1998.16.1.187.
- Background: PubMed 10663639Rosing H, Lustig V, van Warmerdam LJ, Huizing MT, ten Bokkel Huinink WW, Schellens JH, Rodenhuis S, Bult A, Beijnen JH. Pharmacokinetics and metabolism of docetaxel administered as a 1-h intravenous infusion. Cancer Chemother Pharmacol. 2000;45(3):213-8. doi: 10.1007/s002800050032.
- Background: PubMed 11392450Bruno R, Vivier N, Veyrat-Follet C, Montay G, Rhodes GR. Population pharmacokinetics and pharmacokinetic-pharmacodynamic relationships for docetaxel. Invest New Drugs. 2001 May;19(2):163-9. doi: 10.1023/a:1010687017717.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li Zhang principal investigator
Sun Yat-sen University
Shu Sen Wang principal investigator
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PK guided arm and PTX 175mg/m2, DOC 75mg/m2 in people with Non-small Cell Lung Cancer and Breast Cancer, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact YuXiang Ma (86-020-87343786, mayx@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Toxicities rate (time frame: 3 weeks, 6 weeks, 9 weeks, 12 weeks, 15 weeks, 18weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01891123, which also lists 39 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2015.