Lung Cancer Clinical Trial
Official title:
A Phase II Trial of Cloretazine™ (VNP40101M) for Patients With Relapsed or Refractory Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy, such as VNP40101M, work in different ways to stop the
growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well VNP40101M works in treating patients with
recurrent or refractory locally advanced or metastatic small cell lung cancer.
OBJECTIVES:
- Determine the overall response rate (partial and complete) in patients with relapsed or
refractory locally advanced or metastatic small cell lung cancer treated with
VNP40101M.
- Determine the toxic effects of this drug in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to disease state
(sensitive relapse [progressive disease > 3 months after responding to first-line
chemotherapy] vs resistant disease [progressive disease during or ≤ 3 months after
first-line chemotherapy]).
Patients receive VNP40101M IV over 15-30 minutes once weekly for 3 weeks. Treatment repeats
every 6 weeks for up to 6 courses. Patients achieving a complete response (CR) receive 2
additional courses of therapy after CR.
After completion of study treatment, patients are followed periodically for up to 18 months.
PROJECTED ACCRUAL: A total of 87 patients will be accrued for this study.
;
Masking: Open Label, Primary Purpose: Treatment
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