A Phase I Study of PS-341 (NSC 681239), Carboplatin, and Etoposide in Patients With Advanced Solid Tumors Refractory to Standard Therapy
I. Determine the maximum tolerated dose (MTD) of bortezomib, carboplatin, and etoposide in
patients with advanced solid tumors refractory to standard therapy.
II. Evaluate biologic effects of bortezomib on relevant targets in the tumor tissues of
patients treated with this regimen.
OUTLINE: This is a dose-escalation study of bortezomib, etoposide, and carboplatin.
Patients receive bortezomib IV on days 1 and 8, carboplatin IV over 30 minutes on day 1, and
etoposide IV over 60 minutes on days 1-3. Treatment repeats every 21 days for at least 2
courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of bortezomib until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 or more
of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 6 additional
patients with newly diagnosed, chemotherapy-naive extensive stage small cell lung cancer,
and 6 patients with other tumor types, are treated at that dose.
PROJECTED ACCRUAL: A total of 12-27 patients will be accrued for this study within 6-14
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
MTD defined as the dose level below the dose level that results in DLT in >= 2 of 6 new patients assessed using NCI CTC version 2.0
University of Colorado, Denver
United States: Food and Drug Administration
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