Phase I Study of Preoperative Chemo/Radiation (Concurrent Irinotecan/Cisplatin/RT) Followed by Surgery in Limited Stage Small Cell Lung Cancer (SCLC-LS)

OBJECTIVES:

• Determine the safety and feasibility of neoadjuvant chemoradiotherapy with irinotecan and cisplatin followed by surgery in patients with limited stage small cell lung cancer.
• 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.