Lung Cancer Clinical Trial
Official title:
A Phase II Trial of PS-341 (NSC-681239) in Patients With Platinum-Treated Extensive Stage Small Cell Lung Cancer
RATIONALE: Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary
for their growth.
PURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who
have recurrent or refractory extensive-stage small cell lung cancer that was previously
treated with platinum-based chemotherapy (such as cisplatin, carboplatin, or oxaliplatin).
OBJECTIVES:
- Determine the efficacy of bortezomib, in terms of response rate (confirmed and
unconfirmed, complete and partial), in patients with recurrent or refractory extensive
stage small cell lung cancer previously treated with platinum-based therapy.
- Determine the qualitative and quantitative toxic effects of this drug in these
patients.
- Determine the overall survival of patients treated with this drug.
- Correlate selected molecular markers with outcomes in patients treated with this drug.
OUTLINE: Patients are stratified according to platinum-sensitivity status (platinum
sensitive [temporarily closed to accrual as of 8/1/04] vs platinum refractory [temporarily
closed to accrual as of 6/1/04]).
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat
every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 40-80 patients (20-40 per stratum) will be accrued for this
study within 0.5-1 year.
;
Masking: Open Label, Primary Purpose: Treatment
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