Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
University of Wisconsin, Madison
With
OBJECTIVES: Primary * Compare the tumor response rates (complete and partial response) in patients with relapsed or refractory advanced non-small cell lung cancer treated with bortezomib with vs without docetaxel. Secondary * Compare time to progression in patients treated with these regimens. * Compare the overall and 1-year survival of patients treated with these regimens. * Compare the safety and tolerability of these regimens in these patients. * Compare the pharmacokinetics and pharmacodynamics of these regimens in these patients. * Compare the quality of life of patients treated with these regimens. OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. * Arm II: Patients receive docetaxel IV over 1 hour on day 1 and bortezomib IV as in arm I. In both arms, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) receive 2 additional courses beyond confirmation of CR. Quality of life is assessed on day 1 of each treatment course (before drug administration) and at 30 days after the completion of study treatment. Patients are followed at 30 days and then every 3 months for survival. PROJECTED ACCRUAL: A total of 155 patients (75 for arm I and 80 for arm II) will be accrued for this study within 1 year.
Age
18–120
Sex
ALL
Healthy volunteers
Not accepted
