Finding studies
Finding studies
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Lead
National Cancer Institute (NCI)
PRIMARY OBJECTIVE: I. To compare the efficacy and tolerability of sequential vs concurrent docetaxel and bortezomib in patients with previously treated, progressive or recurrent, advanced non-small cell lung cancer (NSCLC). SECOND OBJECTIVES: I. To compare time to progression in patients with previously treated NSCLC treated with these regimens. II. To compare 1-year and overall survival of patients treated with these regimens. III. To compare the toxicity of these regimens in these patients. IV. To determine the pharmacokinetics of docetaxel in the context of this study. TERTIARY OBJECTIVE: I. To determine levels of expression of molecular markers regulated by docetaxel and bortezomib and correlate with clinical response and overall survival of these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to ECOG performance status (0 vs 1) and number of prior chemotherapy treatments (1 vs \>1). Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive docetaxel IV over 60 minutes on day 1 and bortezomib IV over 3-5 seconds on days 1 and 8. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive docetaxel as in arm I and bortezomib IV over 3-5 seconds on days 2 and 8. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed periodically.
Age
18–120
Sex
ALL
Healthy volunteers
Not accepted
