cancer
Conditions
Interventions
PK study in combination with or without aprepitant.
Sponsors
Saitama Medical University, International Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients with histologically or cytologically confirmed solid tumor who are scheduled to receive chemotherapy with docetaxel. 2.Patients with ECOG performance status of 0 to 2. 3.Patients who are 20 years or older. 4.Patients without severe complication, e.g. interstitial pneumonia or pulmonary fibrosis, renal failure, liver failure, incontrollable diabetes or hypertension. 5. The following laboratory conditions within 14 days prior to registration are satisfied. 1) WBC 12000/mm3 or less. 2) neutrophil count 2000/mm3 or higher. 3) Hb 9.0g/dl or higher. 4) platelet count 100.000/mm3 or higher. 5) AST, ALT within 1.5xUNL 6) T.B 1.5mg/dl or less 7) serum Cre within 1.5xUNL 6. Not infected with HCV, HBV or HIV. 7. Patients who gave written informed consent to receive chemotherapy with docetaxel. 8. All patients were asked for written informed consent for their peripheral blood samples and medical research purpose.
Exclusion criteria
Exclusion criteria: 1. Patients with contraindication to docetaxel, involved with bone marrow suppression, active infection, severe hypersensitivity to ingredients contained by docetaxel. 2. Patients with contraindication to aprepitant. 3. Patient with pleural effusion or ascites which should be drainaged. 4. Patients have received chemotherapy including any drug except docetaxel, or radiation therapy within 3 weeks prior to registration. 5. Patients have hormonal therapy within 7 days prior to registration. 6. Women of childbearing potential and men of impregnating potential who don't agree to use adequate contraception, pregnant women, and lactating women. 7. History of severe hypersensitivity to a medicine. 8. Patients with the habit of smoking within one month prior to registration. 9. Patients with any conditions that are unstable or jeopardize the safety of the patient and his/her compliance in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare intra-patient phamacokinetics of docetaxel and dexamethasone under the three different conditions, which are as follows. A : without aprepitant. B1: In combination with aprepitant 3 hours prior to the administration of docetaxel, adjusting timing with Tmax of aprepitant. B2: In combination with aprepitant 1 hour prior to the administration of docetaxel according to the package insert. | — |
Countries
Japan
Outcome results
None listed