A Study of Population Pharmacokinetics of Docetaxel (Taxotere) in Caucasian and African-American Cancer Patients

Date de début de l'étude : 1 septembre 1998

DISEASE CHARACTERISTICS: Histologically proven unresectable solid tumors (e.g., lung, breast, head and neck, bladder) Clinically suitable for treatment with single agent docetaxel Caucasian (at least 2 generations originating in any of the original peoples of Europe, North Africa, or the Middle East) OR African American (at least 2 generations originating in any of the black racial groups of Africa) PATIENT CHARACTERISTICS: Age: 18 and over Performance status: 0-2 Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than upper limit of normal (ULN) AST no greater than 1.5 times ULN AND Alkaline phosphatase no greater than 2.5 times ULN Renal: BUN no greater than 1.5 times ULN Creatinine no greater 1.5 times ULN Other: Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: No prior bone marrow transplantation Chemotherapy: No prior docetaxel Prior paclitaxel allowed 1 or 2 prior chemotherapy regimens allowed At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) No other concurrent chemotherapy Endocrine therapy: No concurrent hormones for disease related conditions Concurrent steroids for adrenal failure allowed Radiotherapy: At least 2 weeks since prior radiotherapy Palliative radiotherapy allowed except whole brain irradiation for CNS disease Surgery: Not specified Other: At least 48 hours since prior or concurrent ethanol (CYP3A enzyme inducer) or grapefruit juice (CYP3A enzyme inhibitor) At least 7 days since prior or concurrent CYP450 inducing drugs: Antiseizure medications: phenobarbital, phenytoin, carbamazepine, or lamotrigine Anti-TB therapy: rifampin, isoniazid, or sulfinpyrazone At least 7 days since prior or concurrent CYP450 3A inhibiting drugs: Macrolides: erythromycin, clarithromycin, azithromycin, or roxithromycin Azoles: ketoconazole, fluconazole, or itraconazole Other antibiotics: metronidazole or chloramphenicol Anti-HIV drugs: ritonavir, indinavir, nelfinavir, or delavirdine Immunosuppressive agents: cyclosporine Antidepressant agent: nefazodone