Finding studies
Finding studies
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Lead
National Cancer Institute (NCI)
PRIMARY OBJECTIVES: I. Determine the safety and feasibility of combining bortezomib with gemcitabine and carboplatin in patients with advanced or recurrent non-small cell lung cancer. II. Determine the maximum tolerated dose of bortezomib administered in combination with gemcitabine and carboplatin in these patients. III. Correlate results from laboratory studies on patient tissue and serum specimens with potential predictors of response in patients treated with this regimen. IV. Determine, preliminarily, the response of patients treated with this regimen. OUTLINE: This is a multicenter, dose-escalation study of bortezomib. Patients receive gemcitabine IV over 30 minutes on days 1 and 8, carboplatin IV over 15-30 minutes on day 1, followed 1 hour later by bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with a clinical or radiographic response may continue receiving bortezomib beyond 6 courses. 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 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, at least 10 additional patients with chemotherapy-naive disease receive treatment as above with the MTD of bortezomib. Patients are followed for survival.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
