Finding studies
Finding studies
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Lead
Northwestern University
With
OBJECTIVES: Primary * To establish the maximum tolerated dose of docetaxel when administered with oxaliplatin and fluorouracil in patients with metastatic or unresectable solid tumors. (Phase I) * To determine the response rate in patients with metastatic or unresectable adenocarcinoma of the stomach or gastroesophageal junction treated with this regimen. (Phase II) Secondary * To determine the dose limiting toxicity of this regimen in these patients. * To evaluate the frequency of CYP3A4, CYP3A5, and MDR polymorphisms and their impact on toxicity of docetaxel. * To evaluate the frequency of XRCC1 and ERCC2 polymorphisms and their impact on the toxicity of oxaliplatin. * To evaluate the frequency of DPD and TSER polymorphisms and their impact on the toxicity of fluorouracil. * To characterize the toxicity profile of this regimen in these patients. OUTLINE: This is a dose-escalation study of docetaxel. Patients receive docetaxel IV over 1 hour and oxaliplatin IV over 2 hours on day 1 and fluorouracil IV continuously over 46 hours on days 1 and 2. Treatment repeats every 14 days for at least 2 courses in the absence of disease progression, symptomatic tumor progression, or unacceptable toxicity. Patients undergo blood sample collection periodically for pharmacokinetic and pharmacogenomic correlative studies. Plasma concentrations of docetaxel are analyzed by reverse-phase high performance liquid chromatography and tandem mass spectrometry. Polymorphisms in CYP3A4/5, MDR, and other genes are analyzed by PCR. After completion of study therapy, patients are followed every 3 months. PROJECTED ACCRUAL: A total of 73 patients (30 for phase I and 43 for phase II) will be accrued for this study.
Age
18–120
Sex
ALL
Healthy volunteers
Not accepted
