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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000003723

Enrollment

Registered

2010-06-07

Start date

2009-07-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Small Cell Lung Cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
the relation between genetic polymorphisms and docetaxel pharmacokinetics	—

Secondary

Measure	Time frame
the association between polymorphisms and toxicity in NSCLC patients receiving docetaxel chemotherapy	—

Countries

Japan

Contacts

Public ContactYoshimasa Shiraishi

Kyushu University Research institute for diseases of the chest

shiraish@kokyu.med.kyushu-u.ac.jp092-642-5378

Outcome results