Unique ID issued by UMIN | UMIN000003723 |
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Receipt number | R000004504 |
Scientific Title | Investigation of influence of genetic polymorphisms of drug metabolizing enzymes and transporters, including SLCO1B3 and ABCC2, on Docetaxel Pharmacokinetics in advanced Non Small Cell Lung Cancer Patients |
Date of disclosure of the study information | 2010/06/07 |
Last modified on | 2011/07/05 10:32:24 |
Investigation of influence of genetic polymorphisms of drug metabolizing enzymes and transporters, including SLCO1B3 and ABCC2, on Docetaxel Pharmacokinetics in advanced Non Small Cell Lung Cancer Patients
influence of polymorphisms of drug metabolizing enzymes and transporters on Docetaxel Pharmacokinetics
Investigation of influence of genetic polymorphisms of drug metabolizing enzymes and transporters, including SLCO1B3 and ABCC2, on Docetaxel Pharmacokinetics in advanced Non Small Cell Lung Cancer Patients
influence of polymorphisms of drug metabolizing enzymes and transporters on Docetaxel Pharmacokinetics
Japan |
Non-Small Cell Lung Cancer
Pneumology | Hematology and clinical oncology |
Malignancy
YES
To describe the population pharmacokinetics of docetaxel in patients with NSCLC, and assess the relationship between docetaxel disposition and genetic polymorphisms , including SLCO1B3 and ABCC2.
Pharmacokinetics
Exploratory
Not applicable
the relation between genetic polymorphisms and docetaxel pharmacokinetics
the association between polymorphisms and toxicity in NSCLC patients receiving docetaxel chemotherapy
Observational
20 | years-old | <= |
Not applicable |
Male and Female
1)Histologically or cytologically confirmed NSCLC
2)Patients with progression or recurrence after platinum-doublet chemotherapy or patients who cannot tolerate first-line platinum-doublet chemotherapy
3)20 years of age or older
4)Presence of at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria
5)Performance Status (ECOG) 0-2
6)Patients who are able to stay in hospital at least for the first two weeks of therapy in principle
7)Adequate organ function obtained within 2 weeks prior to registration. Laboratory values must be as follows;
WBC count >= 3,000 /mm3, and <= 12,000 /mm3
absolute neutrophil count >= 1,500 /mm3, and <= 5,000 /mm3
platelet count >= 100,000 /mm3
hemoglobin >= 9.0 g/dL
AST(SGOT)/ALT(SGPT) <= 2 X institutional upper limit of normal
Total bilirubin less than or equal to 1.5 mg/dL
serum creatinine within 1.5 times the upper limit of normal
SpO2 greater than or equal to 90 % in room air
8) Estimated life expectancy more than 3 months
9) No prior chemotherapy within 4 weeks before enrollment
No prior thoracic radiotherapy within 12 weeks and no prior radiotherapy for metastatic lesions within 2 weeks before enrollment
No prior surgery within 4weeks before enrollment
10) Signed informed consent
1)History of poorly controlled pleural effusion, pericardial effusion and ascites.
2)Active infection
3)Previous severe drug allergy
4)Hoped to be pregnant/nursing.
5)Symptomatic brain metastasis
6)Active concomitant malignancy
7)History of poorly controlled diabetes mellitus
8)History of severe complicating disease
9)simultaneous use of other anti-cancer drugs
10)Those judged to be not suitable by the attending physician
11)History of bone-marrow transplantation
12)Those who received a white blood cell transfusion within 30 days before registration
50
1st name | |
Middle name | |
Last name | Nakanishi Yoichi |
Kyushu University
Research institute for diseases of the chest
Fukuoka city HIgashi-ku Maidashi 3-1-1
092-642-5378
1st name | |
Middle name | |
Last name | Shiraishi Yoshimasa |
Kyushu University
Research institute for diseases of the chest
Maidashi 3-1-1, HIgashi-ku, Fukuoka city
092-642-5378
shiraish@kokyu.med.kyushu-u.ac.jp
Research institute for diseases of the chest, Kyushu University
Research institute for diseases of the chest, Kyushu University
Self funding
NO
九州大学病院呼吸器科
2010 | Year | 06 | Month | 07 | Day |
Unpublished
Open public recruiting
2009 | Year | 06 | Month | 30 | Day |
2009 | Year | 07 | Month | 01 | Day |
2012 | Year | 07 | Month | 01 | Day |
Patients with platinum-refractory non-small cell lung carcinoma or patients who cannot tolerate platinum-doublet chemotherapy are administered single agent docetaxel chemotherapy (standard therapy). Blood samples are collected before and 0, 0.17, 1, 5, 10 and 24 hours after Docetaxel infusion.
2010 | Year | 06 | Month | 07 | Day |
2011 | Year | 07 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004504
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