A Phase I/II Study to Evaluate Safety and Efficacy in Patients Who Have Resectable Esophageal Cancer and Are Treated With Neoadjuvant Cisplatin, Irinotecan (CPT-11) ZD1839 (IRESSA), and Radiotherapy Followed by Surgical Resection
- Evaluate the pathologic response (complete and partial) in patients with resectable
esophageal or gastroesophageal junction cancer treated with neoadjuvant gefitinib,
cisplatin, irinotecan hydrochloride, and radiotherapy followed by surgical resection.
- Assess the safety and toxicity of this regimen in these patients.
- Evaluate objective tumor response in patients treated with this regimen.
- Determine the rate of complete resection in patients treated with this regimen.
- Determine surgical morbidity and mortality in patients treated with this regimen.
OUTLINE: This is an open-label study.
- Induction phase: Patients receive oral gefitinib once daily on days 1-14. Patients with
stable or responding disease proceed to neoadjuvant chemoradiotherapy.
- Neoadjuvant chemoradiotherapy: Patients receive gefitinib as in the induction phase
beginning in week 4 and continuing through the last day of radiotherapy. Patients also
receive cisplatin IV over 1 hour and irinotecan hydrochloride IV over 30 minutes on
days 22, 29, 43, and 50 and undergo radiotherapy once daily, 5 days a week, for 5 weeks
(total of 25 doses).
- Surgery: Within 4-8 weeks after completion of neoadjuvant chemoradiotherapy, patients
with stable or responding disease undergo an esophagectomy and lymph node dissection.
Patients with a progressive or unresectable disease are removed from the study.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Pathological response (complete and partial) post-operatively
Andrew Ko, MD
University of California, San Francisco
United States: Food and Drug Administration
|UCSF Helen Diller Family Comprehensive Cancer Center||San Francisco, California 94115|