Cancer
Conditions
Interventions
Microdosing, standard dosing
Sponsors
Saitama Medical University, International Medical Center, Department of Medical Oncology
Tokyo University, Graduate School of Pharmaceutical Sciences, Department of Molecular Pharmacokinetics
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients with histologically confirmed solid tumors. 2)Patients who are candidates of docetaxel treatment. 3)Patients with breast cancer, non-small cell lung cancer, stomach cancer, head and neck cancer, esophargus cancer, ovarian cancer or uterine body cancer that are approved by Miritary of Health, Labor and Wealfare to be treated with docetaxel. Patients with adenoid cystic carcinoma, carcinoid, unknown primary tumor or soft tissue sarcoma which are not proved the no effects of docetaxel. 4)Patients with unresectable, locally advanced, metastatic or recurrent tumor. 5)Patients with measurable and evaluable lesion(s). 6)Patients who are 20 years or higher. 7)Patients with ECOG performance status of 0 to 2. 8)Patients who are expected to live at least 3 months or more. 9)No history of chemotherapy, hormonetherapy or molecularly targeted therapy within 3 weeks. 10)No history of radiotherapy within 2 weeks 11)Patients with adequate organ functions. 12)Inclusion criteria observed within 1 week. 1. WBC count 1000 /mm3 or higher. 2. Neutrophil count 1500 /mm3 or higher. 3. Platelet count 100,000 /mm3 or higher. 3. Hemoglobin 9.0 g/dL or higher. 4. AST, ALT less than 2.0 times the upper limit of normal. 5. Total bilirubin 2.0 mg/dL or less. 6. AST, ALT less than twice as high as upper limit of normal 7. Serum creatinine 1.2 mg/dLor less. 8. Creatinine clearance 60 mL/min or higher (Cockcroft-Gault equation) 13)All patients were asked for written informed consent for their peripheral blood samples and medical information to be used for research purposes.
Exclusion criteria
Exclusion criteria: 1)Patients with severe allergy or those who had severe allergy in the past (including that for polysorbate 80). 2)Pregnant patients. Men and women who want to make baby. 3)Ptisnts with active infection. HCV, HBs or HIV positive. 4)Patients with severe complications (interstitial pneumonia or pulmonary fibrosis, renal failure, liver failure, incontrollable diabetes or hypertension). 5)Patients with cardiovascular disease or showing severely atypical electro cardiogram. 6)Patients with gastrointestinal ulcer or related bleeding. 7)Patients with uncontrollable diarrhea. 8)Patients with brain metastasis with any symptoms or those without any symptoms with steroid medication. 9)Patients with pleural fluid or abdominal dropsy which is required medical intervention. 10)Patients who experienced thromboembolism, stroke or pulmonary infarction. 11)Patients who receive operation within 28 days. 12)Patients with inborn hemorrhagic diathesis, coagulation disorder or those with DIC. 13)Patients having anticoagulant including aspirin or warfarin. 14)Patients with continuous steroid therapy. 15)Patients who do not understand this study well. 16)Patients who are not appropriate to participate in the study safely.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare pharmacokinetics of docetaxel seen after the microdosing with those observed after the standard dosing in patients with tumor | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacogenetic analysis for factors responsible for the metabolism or transport of docetaxel | — |
Countries
Japan
Outcome results
None listed