Phase I Study of Preoperative Chemo/Radiation (Concurrent Irinotecan/Cisplatin/RT) Followed by Surgery in Limited Stage Small Cell Lung Cancer (SCLC-LS)
- Determine the safety and feasibility of neoadjuvant chemoradiotherapy with irinotecan
and cisplatin followed by surgery in patients with limited stage small cell lung
- Determine the pathologic complete response rate of patients treated with this regimen.
- Correlate the level of vascular endothelial growth factor with treatment response and
disease outcome in patients treated with this regimen.
- Correlate genetic polymorphisms in cytochrome P450 1A1, glutathione S-transferase M1
and P1, myeloperoxidase, and NAD(p)H: quinone oxidoreductase with treatment response
and disease outcome in patients treated with this regimen.
OUTLINE: This is a pilot study.
- Induction chemotherapy: Patients receive cisplatin IV over 1 hour on day 1 and
irinotecan IV over 90 minutes on days 1 and 8.
- Chemoradiotherapy: Beginning on day 21, patients receive chemoradiotherapy comprising
radiotherapy once daily, 5 days a week for 4 weeks and then twice daily for 4 days.
Patients also receive cisplatin IV and irinotecan IV over 30-60 minutes once weekly
concurrently with radiotherapy. Treatment continues in the absence of disease
progression or unacceptable toxicity.
At the completion of chemoradiotherapy, patients are evaluated for surgery. Patients who are
candidates for surgery receive one additional course of cisplatin IV and irinotecan IV.
Patients who are not candidates for surgery receive radiotherapy twice daily for 4 days and
cisplatin IV and irinotecan IV as in chemoradiotherapy.
- Surgery: Approximately 2-4 weeks after the last dose of chemotherapy, patients undergo
Patients are followed every 4 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Primary Purpose: Treatment
Steven Feigenberg, MD
Fox Chase Cancer Center
United States: Federal Government
|Fox Chase Cancer Center||Philadelphia, Pennsylvania 19111|