Lung Cancer Clinical Trial
Official title:
Pilot Study of a Combination of Standard Etoposide/Cisplatin and Metronomic Cyclophosphamide in Patients With Newly Diagnosed Extensive Stage Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy, such as cisplatin, etoposide, and cyclophosphamide,
work in different ways to stop tumor cells from dividing so they stop growing or die.
Combining more than one chemotherapy drug may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving cisplatin, etoposide, and
cyclophosphamide together works in treating patients with extensive-stage small cell lung
cancer.
OBJECTIVES:
Primary
- Determine the safety of cisplatin, etoposide, and cyclophosphamide in patients with
extensive stage small cell lung cancer.
- Determine the effect of this regimen on circulating endothelial cells in the peripheral
blood of these patients.
Secondary
- Determine progression-free survival, tumor response rate, and overall survival in
patients treated with this regimen.
OUTLINE: This is a multicenter study.
- Induction therapy: Patients receive cisplatin IV over 30 minutes-2 hours on day 1,
etoposide IV over 1-2 hours on days 1-3 OR etoposide IV on day 1 and orally twice daily
on days 2-3, and oral cyclophosphamide twice daily on days 8-19. Treatment repeats
every 21 days for 4 courses in the absence of disease progression or unacceptable
toxicity.
- Maintenance therapy: Patients receive oral cyclophosphamide twice daily in the absence
of disease progression.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.
PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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