Randomized Phase II Trial of Sequential Versus Concurrent Docetaxel and PS-341 (NSC 681239, IND 58,443) in Previously Treated Non-Small Cell Lung Cancer
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).
I. To compare time to progression in patients with previously treated NSCLC treated with
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.
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rate for PS-341 and docetaxel given in two sequences and to decide whether this combination warrants further study
This objective corresponds to a one-sided test at the 0.5 level of significance, with 90% power.
Up to 4 years
City of Hope Medical Center
United States: Food and Drug Administration
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